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UC Cancer Center Clinical Trials



Clinical trials are a means of developing new medicines, devices or procedures for the purpose of gaining medical knowledge relevant to the prevention, detection, diagnosis, control, and treatment of medical diseases and conditions. More specifically, clinical trials are scientific studies designed to evaluate one or more groups of subjects, using one or more types of interventions. The predominant intervention studied in clinical research is medicine. Consequently, experimental drugs are the focus of this website.
  • Learn about the phases throughout a clinical trial: download pdf.
  • Learn about the terminology commonly used in clinical trials: download pdf.
  • View a list of individuals involved in UC clinical trials: click here.

Current Clinical Trials
Click on the clinical trial category to jump directly to all clinical trials pertaining to the category:



General Clinical Trials

There are no trials under this category at this time.

 





Brain Cancer Clinical Trials

Topic: Brain Cancer (Glioblastoma)

Title: RTOG 0525 Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

Place: The Barrett Cancer Center and University Pointe

Enrollment Dates: April 2006 to 2010 (approx.)

Overview: A recent study demonstrated that combining a drug called temozolomide with radiation treatment and following this treatment with temozolomide treatment improved tumor control compared with radiation alone.The purpose of this study is to determine whether increasing the duration of the temozolomide treatment after radiation from 5 days out of 28 days (standard-dose schedule) to 21 days out of 28 days (dose-dense schedule) will further improve the outcome of your disease.

Qualifications:
-Enrollment in the study will be based upon confirmation that your tumor is a glioblastoma
-Must be at least 18 years of age or older

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Brain Tumor

Title: RTOG 0424, A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas

Place: The Barrett Center and University Pointe

Enrollment Dates: Now through April 2008

Overview: The purpose of this study is to determine whether a drug called temozolomide combined with radiation will control your tumor longer than radiation alone or radiation combined with other chemotherapy drugs used in previous clinical trials. Temozolomide is FDA approved for some types of brain tumors, however it is not currently approved for low-grade gliomas. This study will find out what effects, good and/or bad this drug has on you and on your tumor.

Qualifications: Must have a low-grade glioma brain tumor.

How to sign up: Call (513) 584-7698 or (888) 724-5959.



Breast Cancer Clinical Trials


Topic:
Breast Cancer

 

Title: MAP.3 A Phase 3 randomized study of Exemestane versus placebo in women at an increased risk of developing breast cancer.

 

Enrollment Dates: Ongoing

 

Place: The Barrett Cancer Center, Medical Arts Building and University Pointe.

 

Overview: This 5-year study is designed for women who are post-menopausal and at a higher risk of developing breast cancer, either due to a personal or family history of breast cancer.  This is comparing Exemestane, a drug that is already FDA approved for treating certain types of breast cancer to a placebo (a sugar pill) taken once a day for 5 years.

 

Qualifications: Women must be 35 or older and post-menopausal for at least one year. This can be natural menopause or due to surgery. Calculations are performed to confirm that the potential patient is at a higher risk of developing breast cancer and these calculations must at least meet the minimum number to qualify. Women must not have taken hormone replacement therapy within the past 90 days.

 

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic:  Breast Cancer

 

Title:  NSABP PROTOCOL BP-59, Bone Marrow Analysis in Early-Stage Breast Cancer

 

Trial Dates:  Ongoing

 

Place:  The Barrett Cancer Center, Medical Arts Building and University Pointe.

 

Overview:  Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment.  This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer. Patients undergo bone marrow aspiration during surgical resection of the primary tumor.  Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry.  Patients are followed every 12 months for up to 10 years.  A total of 1,634 patients will be accrued for this study within 3 years.

 

Qualifications:  Eligible patients must be at least 18 years of age and have early-stage breast cancer.

 

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

 

Topic:  Breast Cancer

 

Title:  Aptium Oncology protocol # 06-BR-01, A Phase II Study of Pre-operative Pegylated Liposomal Doxorubicin – PLD (Doxilâ), Paclitaxel (Taxolâ), and Trastuzumab (Herceptinâ) in Patients with Operable Breast Cancer Over-expressing Her2-neu

 

Trial Dates:  Ongoing

 

Place:  The Barrett Center, The Medical Arts Building, University Pointe

 

Overview:  The current study will evaluate the safety and efficacy of the pre-operative regimen Doxilâ, Taxolâ, and Herceptinâ in previously untreated over-expressing Her2-neu breast cancer patients.  Laboratory studies and disease assessments will be done throughout treatment to monitor how well the drug regimen is working and how well you tolerate it.

 

A suitable response rate and a satisfactory toxicity profile would permit use of this regimen in the advanced disease environment, as well as in the adjuvant setting. Appropriate safety and efficacy would also permit incorporation of this treatment regimen into a subsequent pre-operative study program (PREMIER) designed to identify predictive markers indicative of response to varying regimens of breast cancer chemotherapy.

 

Up to 30 patients with over-expressing Her2-neu breast cancer will participate at approximately 10 Aptium Oncology Comprehensive Cancer Centers and affiliated medical institutions and hospitals.

 

Qualifications:  Qualified participants must be at least 21 years of age and have breast tumor that has an overactive gene called human epidermal growth factor receptor 2(Her2-neu).  Also, eligible patients must have not previously received chemotherapy or other agents for the treatment of breast cancer and your study doctor feels you are to be of sufficient risk of relapse to warrant undergoing chemotherapy treatment.

 

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

 

Topic: Breast Cancer

 

Title: IBCSG 24-02  A phase 3 trial evaluating the role of Ovarian function suppression and the role of Exemestane as an adjuvant therapy for premenopausal women endocrine responsive breast cancer

 

Enrollment Dates: Ongoing

 

Place:  The Barrett Center, Medical Arts Building and University Pointe.

 

Overview: This 6 year long study is designed for women who are pre-menopausal and have had surgery for their breast cancer.  Participants will go into 1 of 3 treatment groups:  Tamoxifen alone; Suppressing the function of the ovaries plus Tamoxifen; or Suppressing the function of the ovaries plus Exemestane.

 

Qualifications:

·         Women must be 18 or older and pre-menopausal.

·         Chemotherapy is not required for this study but if utilized, must be completed prior to study entry and blood tests will be done to confirm pre-menopausal status.

·         Cancer must be confined to the breast and not spread to any other area.

·         Contact the study coordinators listed below for other study qualifications.

 

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic: Breast Cancer

Title: NSABP PROTOCOL B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building and University Pointe

Overview: The main purpose of the study is to learn whether or not continuing hormonal therapy with an aromatase inhibitor (AI) called letrozole for 5 additional years after already taking 5 years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer returning. Letrozole is investigational (still being researched) for use in patients who have already received an AI as part of their 5 years of hormonal therapy. Letrozole is considered investigational because it has not yet received approval from the Food and Drug Administration (FDA) or the Canadian Health Products and Food Branch (HPFB) for use after 5 years of hormonal therapy which included an AI. Eligible patients will be randomized to receive either letrozole 2.5 mg or a placebo that looks like letrozole. Letrozole/placebo should begin within 30 days following randomization and is to be given continuously for 5 years from the date of the first dose (regardless of missed doses or drug holidays). After completing the letrozole/placebo, study staff will contact patients every year for the rest of their lives to follow their health.

Qualifications: Postmenopausal women with ER and/or PgR-positive invasive breast cancer who have completed 5 years of hormonal therapy consisting of either 5 years of an aromatase inhibitor (AI) or up to 3 years of tamoxifen followed by an AI (for a total of 5 years)

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic: Breast Cancer

Title: ECOG PACCT-1 Trial-Program for the Assessment of Clinical Cancer Tests (PACCT-1):Trial Assigning Individualized Options for Treatment:The TAILORx Trial

Enrollment Dates: August 2006 startup

Place: The Barrett Center, Medical Arts Building and University Pointe

Overview: This study is being done because chemotherapy would normally be recommended for the treatment of this disease to lower the risk of breast cancer recurring.The purpose of this study is to determine whether patients who have a tumor with a recurrence score equal to or below 10 may be cured with hormonal therapy alone.Another objective is to create a tissue and blood specimen bank that includes specimens from all women who participate in the study so as to allow researchers to evaluate new diagnostic tests for the future.

Qualifications: To qualify for this trial, women must be age 18 or older and have breast cancer that is estrogen receptor and/or progesterone receptor positive that has not spread to the axillary lymph nodes.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Breast Cancer

Title: NSABP B-36 A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin, and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node-Negative Breast Cancer

Enrollment Dates: Now through December 2007

Place: The Barrett Center, Medical Arts Building and University Pointe

Overview: The primary aim of this study is to determine whether a regimen of six cycles of 5-fluoruracil (5-FU), epirubicin and cyclophosphamide (FEC-100) is superior to four cycles of Adriamycin and cyclophosamide (AC) in prolonging disease-free survival in patients with node-negative breast cancer.

Qualifications: To qualify for this trial, women must have invasive breast cancer with negative nodes and must have undergone a lumpectomy or mastectomy plus axillary node dissection or sentinel node biopsy. All women with tumors that are hormone receptor positive will receive hormonal therapy upon completion of chemotherapy. Please contact the study coordinator listed below for more details.

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic: Chemotherapy Study for patients with Metastatic Breast Cancer

Title: A Phase II Trial of Biweekly Gemcitabine, Paclitaxel and Bevacizumab as Frontline Therapy for Metastatic Breast Cancer

Enrollment Dates: May 2006 through May 2008

Place: The Barrett Center

Overview: In this study it is to be determined how the combination of the drugs Gemcitabine, Paclitaxel and Bevacizumab given biweekly will work against Metastatic Breast Cancer

Qualifications: 18 years of age or older, diagnosed with Metastatic Breast Cancer.

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic:  Breast Cancer

 

Title:  SWOG S0622, Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer

 

Trial Dates:  Ongoing

 

Place:  The Barrett Center, Medical Arts Building, University Pointe

 

Overview:  Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.  This randomized, phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.  Eligible patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs no).  Patients are randomized to 1 of 2 treatment arms.  Arm I: Patients receive oral dasatinib once daily.  Arm II: Patients receive oral dasatinib twice daily.  In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity.  Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24.  Samples are analyzed for tumor markers, circulating tumor cells, and bone markers.  Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks 8, 16, and 24.  After completion of study treatment, patients are followed every 3-6 months for up to 2 years.  A total of 80 patients will be accrued for this study, with about four accrued locally.

 

Qualifications:  Eligible patients must be at least 18 years of age and have breast cancer that has spread to other parts of the body.

 

How to sign up: Call (513) 584-7698 or (866) 724-CURE.




Gastronintestinal Cancer Clinical Trials

Topic: Esophageal cancer

Title: SWOG 0356, Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates.

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center

Overview: The purpose of this trial is to find out what effects (good and bad) being treated with oxaliplatin and 5-FU plus radiation therapy before surgery have on patients and their esophageal cancer and whether this treatment before surgery will increase the chance that the surgeon can remove all of the cancer during surgery. The researchers also want to know whether treatment with oxaliplatin and 5-FU after surgery will benefit patients. 5-FU is commonly used to treat esophageal cancer, and oxaliplatin is being used as an investigational study drug for esophageal cancer. Qualified patients will receive preoperative radiation treatments as well as chemotherapy with oxaliplatin and 5-FU. This part will take six weeks to complete. Two to three weeks following chemoradiation, re-examination will take place. As long as the cancer has improved or not gotten worse, surgery will follow. Treatment after surgery will consist of chemotherapy with oxaliplatin and 5-FU. It will begin four to 10 weeks following surgery and will last five weeks.

Qualifications: Primary biopsy proven, non-recurrent adenocarcinoma of the thoracic esophagus or GE junction, Clinical stage II or III disease. May not have had prior chemo or radiation for this tumor. No previous resection or attempted resection of an esophageal cancer.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

 

Topic: Advanced Aerodigestive Tract Cancers

 

Title: A Phase 2 Study of Temozolomide (SCH 52365) in Subjects with advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltrasferase (MGMT) Promoter (Protocol No. 4273)

 

Enrollment Dates: November 2006 thru June 2008

 

Place: Barrett Cancer Center

 

Overview: To determine the response rate for Temozolomide when given on days 1 to 7 and 15 to 21 of each 28-day cycle in subjects with Advanced  Aerodigestive Cancers

 

Qualifications: 18 years of age or older and diagnosed with advanced aerodigestive cancers

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic: Chemotherapy Study for Patients with Advanced Biliary Cancer

 

Title: A Phase II, Multi-center, Open-label Trial to Evaluate the Efficacy and Safety of DAVANAT® in Combination with 5-Fluorouracil When Administered as First Line Chemotherapy in Patients with Advanced Biliary Cancer

 

Enrollment Dates: September 2006 thru September 2008

 

Place: Barrett Cancer Center

 

Overview: In this study, a drug called DAVANAT will be given in combination with the drug 5-Fluorouracil (5-FU) to determine if the combination of DAVANAT plus 5-FU will work against advanced Biliary Cancer

 

Qualifications: 18 years of age or older, diagnosed with advanced Biliary Cancer (Cholangiocarcinoma)

 

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic: Rectal Cancer

Title: CTSU E5204, Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center

Overview: This study is being done to compare the effects (good and bad) of a combination of chemotherapy drugs, when given with and without a new drug, bevacizumab, after patients with stage II or stage III rectal cancer have had pre-operative chemoradiation. The chemotherapy drugs given in this study are 5-fluorouracil (5-FU), leucovorin, and oxaliplatin.The researchers want to see if adding bevacizumab to the other cancer-fighting agents is better for treating rectal cancer patients.The researchers also want to see if adding bevacizumab will help prevent the cancer from coming back.The treatment period on the study is approximately 6 months.The study doctors will follow subjects' medical condition for a period of 10 years after entering the study, to look at the long-term effects of the treatment.

Qualifications: Qualified participants must be at least 18 years of age, have stage II or III rectal cancer, and have already received chemotherapy, radiation, and surgery for disease treatment.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

 

Topic: Study of Oxaliplatin-induced neuropathy in patients with colorectal cancer

Title: Phase II Study of the Efficacy of Amifostine (Ethyol) in reducing the Incidence and severity of Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer

Enrollment Dates: August 2006 through August 2008

Place: The Barrett Center

Overview: This study will evaluate the use of intravenous Amifostine for reducing the incidence of oxaliplatin-induced neuropathy in patients with colorectal cancer.

Qualifications: 18 years of age or older, diagnosed with colorectal cancer

How to sign up: Call (513) 584-7698 or (866) 724-CURE.

 

 

Topic:  Colorectal

 

Title:  SWOG S0600, Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) with or without Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX or XELOX

 

Trial Dates:  Ongoing

 

Place:  The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center

 

Overview:  This randomized phase III trial is studying irinotecan and cetuximab to compare how well they work with or without bevacizumab in treating patients with metastatic colorectal cancer that progressed during first-line therapy.  Eligible patients are stratified according to Zubrod performance status, discontinuation of oxaliplatin during first-line therapy, planned concurrent chemotherapy (FOLFIRI vs single-agent irinotecan hydrochloride), and time from last dose of bevacizumab (14-42 days vs ? 43 days). All patients receive either single-agent irinotecan hydrochloride ( by IV every 21 days in the absence of disease progression or unacceptable toxicity) or FOLFIRI (by IV every 14 days in the absence of disease progression or unacceptable toxicity).  Patients are then randomized to 1 of 3 treatment arms.  Arm I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab IV.  Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.  Arm II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive bevacizumab IV.  Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.  Arm III: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive a higher dose of bevacizumab (higher than in arm II) IV.  After completion of study treatment, patients are followed every 6 months for up to 3 years.  A total of 1,260 patients will be accrued for this study, with about 10 accrued locally.

 

Qualifications:  Eligible patients must be at least 18 years of age and have colorectal cancer that has spread and that has not responded to prior treatment that included bevacizumab.

 

How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959.  You will be connected to the Research Coordinator for this study.

 

 

 

Topic: Advanced Pancreas Cancer

 

Title: A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5-Fluorouracil and Bevacizumab in Patients with Advanced Pancreas Cancer

 

Trial Dates: November 2006 thru June 2008

 

Place: Barrett Cancer Center

 

Overview: In this study the combination of the drugs Gemcitabine, 5-fluorouracil and bevacizumab will be tested for safety, tolerability and effectiveness to treat subjects with advanced cancer of the pancreas.

 

Qualifications: 18 years of age or older diagnosed with advanced pancreas cancer.

 

How to sign up: Contact UC Cancer Center at 513-584-7698 or 1-866-724-CURE.



Genitourinary Cancer Clinical Trials


Topic: Renal (kidney) cancer

Title: CTSU E2805, A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma

Enrollment Dates: Ongoing

Place: The Barrett Center, The Medical Arts Building, University Pointe, Veterans Affairs Medical Center

Overview: Sunitinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.  Giving sunitinib or sorafenib after surgery may kill any tumor cells that remain after surgery.  It is not yet known whether sunitinib is more effective than sorafenib or placebo in treating kidney cancer.  This randomized phase III trial is studying sunitinib to see how well it works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery.  A total of about 1,332 people will take part in this study at multiple institutions across the country, with approximately five participating locally.

Qualifications: Qualified participants must be at least 18 years of age and have kidney cancer which has just been removed or is about to be removed and is thought to be at high risk of recurrence.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

 

Topic: Chemotherapy Study for Patients with Metastatic  Clear Cell Carcinoma of the Kidney

 

Title: A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastatic Clear cell Carcinoma of the Kidney

 

Trial Dates: June 2007 thru June 2008

 

Place: Barrett Cancer Center

 

Overview: In this study the drug AMG 386 will be given in combination with Sorafenib and compared to Sorafenib plus placebo as first line treatment therapy for subjects will Metastatic Clear cell Carcinoma of the Kidney 

 

Qualifications: 18 years of age or older with histologically confirmed metastatic Renal Cell Carcinoma with a clear cell component

 

How to sign up: Contact UC Cancer Center at 513-584-7698 or 1-866-724-CURE.

 

 

 

Topic: Prostate Cancer

Title: RTOG 0415 -A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer

Enrollment Dates: Ongoing

Place: Barrett Cancer Center, University Hematology Oncology Care, Veterans Affairs Medical Center and University Pointe

Overview: The purpose of this study is to compare the effects (good and bad) on you and your cancer of the standard dose of radiation therapy (41 treatments over 8 weeks) with a higher daily dose (experimental) of radiation (28 treatments over 5 and a half weeks) to see if the effects of the treatments are similar.

Qualifications:

·         Age 18 or older

·         Have Prostate Cancer and your doctor has recommended external beam radiation therapy

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Prostate Cancer

Title: RTOG 0126 A Phase III Randomized Study of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer

Enrollment Dates: Now through January 2008

Place: The Barrett Center and Veterans Affairs Medical Center

Overview: One of the standard treatment options for this stage and type of prostate cancer is external beam radiation therapy. Modern radiation therapy planning methods with three dimensional (3D) therapy or Intensity Modulated Radiation Therapy (IMRT) allow safer delivery of higher than conventional doses of radiation. The purpose of this study is to compare the effects (good and bad) on you and your cancer of the standard dose of radiation therapy (39 treatments) with a higher dose of radiation (44 treatments) to see which treatment is better.Both three-dimensional radiation therapy and IMRT allow the radiation beam to treat an area that is shaped like your tumor and also to penetrate as deeply as your tumor is located. By treating this way, the dose of radiation to the healthy areas near your tumor is minimized, and the dose to your tumor is maximized. This research is being done to find out whether or not doses higher than the standard can control your cancer without increased side effects.

Qualifications: Must be at least 18 years of age or older. Must have prostate cancer

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

 

Topic: Prostate Cancer

Title: RTOG 0521 A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT VS AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized High Risk Prostate Cancer

Place: Barrett Cancer Center, University Pointe and Veterans Affairs Medical Center

Enrollment Dates: April 2006 to 2012 (approx.)

Overview: The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for the patient?s stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer combines radiation therapy and hormonal therapy. In this study all patients will receive both of these. In addition, half the patients will also receive chemotherapy drugs for about 4-5 months. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is investigational in this stage of prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments.

Qualifications:
Must be at least 18 years of age or older 
Must be localized cancer which has not spread to other tissue 
Must have physician-diagnosed prostate cancer at high risk for recurrence.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Prostate Cancer

Title: RTOG 0518, A Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center

Overview: Hormone therapy can help to control prostate cancer, but it also can cause bone fractures (breaks).These breaks are a result of weak bones (osteoporosis). The purpose of this study is to compare the effects, good and/or bad, of a drug, zoledronic acid (Zometa®), plus vitamin D and a calcium supplement, with a placebo (an inactive drug) plus vitamin D and a calcium supplement.Zoledronic acid is a drug given through the vein to strengthen bones.Zoledronic acid is approved by the FDA for treatment of cancer-related bone complications (such as weak bones).

The study is being done to find out if zoledronic acid prevents bone fractures by strengthening bones better than vitamin D and calcium alone.In this study, subjects will get zoledronic acid plus vitamin D and a calcium supplement or the placebo plus vitamin D and a calcium supplement. Subjects on this study will receive treatment (or placebo) and will be seen every three months for three years.

Qualifications: Qualified participants must be at least 18 years of age, haveprostate cancer, and be receiving radiation therapy and hormone therapy as part of disease treatment.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Prostate Cancer

Title: CALGB 90202, A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center

Overview: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases. Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.

This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study.Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (< upper limit of normal [ULN] vs ULN).P atients are randomized to 1 of 2 treatment arms.Patients in Arm I receive zoledronate IV over 15 minutes on day 1. Patients in Arm II receive placebo IV over 15 minutes on day 1. In both arms, courses repeat every 4 weeks in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy. Patients also receive oral calcium and cholecalciferol (vitamin D) supplements daily.

Patients progressing to androgen-independent prostate cancer proceed to open-label therapy comprising zoledronate IV over 15 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or a skeletal-related event. Patients are followed periodically for approximately 10 years after randomization.Projected accrual is a total of 680 patients (340 per treatment arm) will be accrued for this study within 4 years.

Qualifications: Qualified participants must be at least 18 years of age and have uveal melanoma that has returned after treatment or has spread to other parts of his/her body.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Prostate Cancer

 

Title: SWOG S0421, Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo For Patients with Advanced Hormone Refractory Prostate Cancer

Enrollment Dates:  Ongoing

 

Place: The Barrett Cancer Center, Medical Arts Building, University Pointe, Veterans Affairs Medical Center

 

Overview: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.  This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy. Eligible patients are randomized to 1 of 2 treatment arms.  Patients in Arm 1 receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients in Arm II receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry. About five people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center.  Approximately 930 people will take part in this study at multiple institutions across the country. 

 

Qualifications: Qualified participants must be at least 18 years of age and have prostate cancer that is not responding well to treatment.

 
How to sign up: Call (513) 584-7698 or (888) 724-5959.



Head and Neck Cancer Clinical Trials

 

Topic: Head and Neck Cancer

Title: RTOG 0522, A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

Place: The Barrett Center, Medical Arts Building and University Pointe

Enrollment Dates: Ongoing

Overview: The purpose of this study is to compare the effects, good and/or bad, of radiation therapy and chemotherapy (cisplatin) with radiation therapy, chemotherapy, and cetuximab (C225) on you and your advanced head and neck cancer to find out which is better. In this study, you will get either radiation and cisplatin or radiation, cisplatin, and cetuximab. Cisplatin and radiation are standard treatments for head and neck cancer. Cetuximab is experimental treatment for patients with your type of cancer when used in combination with chemotherapy and radiation therapy.

Qualifications: Must be at least 18 years of age. Must have advanced head and neck cancer with no previous treatment.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Metastatic or Recurrent Head and Neck Cancer

 

Title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm

 

Enrollment Dates: June 2007-June 2009

 

Place: The Barrett Center and Medical Arts Building

 

Overview: This study will look at whether panitumumab, in combination with chemotherapy, is safe and effective in people with head and neck cancer.

 

Qualifications: 18 years of age and older with head and neck cancer

 

How to sign up: Call (513) 584-7698 or (866) 724-2873.

 

 

Topic: Advanced Aerodigestive Tract Cancers

 

Title: A Phase 2 Study of Temozolomide (SCH 52365) in Subjects with advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltrasferase (MGMT) Promoter (Protocol No. 4273)

 

Enrollment Dates: November 2006 thru June 2008

 

Place: Barrett Cancer Center

 

Overview: To determine the response rate for Temozolomide when given on days 1 to 7 and 15 to 21 of each 28-day cycle in subjects with Advanced  Aerodigestive Cancers

 

Qualifications: 18 years of age or older and diagnosed with advanced aerodigestive cancers

How to sign up: Call (513) 584-7698 or (866) 724-CURE.


 


Leukemia Clinical Trials

Topic: Leukemia

 

Title: SWOG S0605, A Phase II Study of Lenalidomide (Revlimid) (NSC-703813) for Previously Untreated Non-M3 Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy

Enrollment Dates: Ongoing

Place:  The Barrett Center, Medical Arts Building, University Pointe and the Veterans Affairs Medical Center

Overview:  Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.  This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q.  During the first part of the study (Induction therapy, patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1).  Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy.  Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy.  During the second part of the study (Maintenance therapy), beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21.  Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years.  A total of about 40 patients will be put on this study, with approximately five patients participating locally.

Qualifications: Qualified participants must be at least 18 years of age and have acute myeloid leukemia (AML) that has not been treated.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

 

Topic: Philadelphia chromosome positive chronic myelogenous leukemia

 

Title: A phase III multi-center, open-label, randomized study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

 

Trial Dates: Oct. 2007 – Oct. 2009

 

Place: Barrett, MAB

 

Overview: The study compares nilotinib with imatinib. Nilotinib targets the same abnormal protein (Bcr-Abl) as imatinib. Nilotinib is currently being tested in patients who are not responding to imatinib, but this study is the first trial in which the effects of nilotinib are being directly compared to that of imatinib.

 

Qualifications: 18 years of age or older and have been diagnoised with Philadelphia chromosome positive chronic myelogenous leukemia

 

How to sign up: Contact UC Cancer Center at 513-584-7698 or 1-866-724-2873.

 

 

 

Topic: Chronic Myelogenous Leukemia (CML)

Title: SWOG S0325:A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase

Enrollment Dates: Ongoing

Place: The Barrett Center, University Hematology Oncology Care and Veterans Affairs Medical Center

Overview: The purpose of this study is to find out if giving a larger dose of imatinib will have any effect on CML.One goal of this study is to find out which treatment works the best for CML in chronic phase when comparing imatinib therapy at standard doses with higher doses of imatinib therapy.

Qualifications: Must be age 18 or older and have chronic myelogenous leukemia in chronic phase.

How to sign up: Call (513) 584-7698 or (888) 724-5959.




Lung Cancer Clinical Trials



Topic:
Lung Cancer

Title: E5597 Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center

Overview: The study will evaluate how effective taking selenium everyday is in decreasing the number of second primary lung tumors in patients who have been treated for Stage I Non Small Lung Cancer by completely removing their tumor. The study wants to find out the number and severity of side effects people experience when they take selenium every day. The study will compare the overall survival of patients treated with selenium to those patients who are taking placebo. It will also compare the number of occurrences of specific cancers and cancer related deaths in both groups. Treatment consists of taking 1 pill of either selenium or placebo every day for four years.

Qualifications:

  • You must have had a Stage IA non small cell lung cancer that has been completely removed by surgery and are currently free of disease.
  • You must have had at lease one mediastinal lymph node biopsied at the time of your surgery.
  • It must have been at least 6 months and no more than 36 months since your surgery.
  • There must be pathology material from the first diagnosis of your non small cell lung cancer available for review if your cancer recurs.
  • You may not have had any chemotherapy or radiation for your lung cancer.
  • You must be at least 18 years old.
  • Your blood tests that show how well your liver is working, must be within a specified range.
  • You must not be taking or plan to take any dietary supplement that contains 50ug or more of selenium.
  • You may not have had any other type of cancer except localized, non melanoma skin cancer within the past 5 years.



How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic: Lung Cancer

Title: ACOSOG Z4032 A Randomized Phase III Study of Sublobar Resection versus Sublobar Resection plus Brachytherapy in High Risk Patients with Non-Small Cell Lung Cancer (NSCLC), 3 cm or Smaller.
Enrollment dates: Ongoing

Place: The Barrett Center, University Hospital, Veterans Affairs Medical Center and University Pointe

Overview: The purpose of this study is to compare the results of sublobar resection (removal of a small portion of a lung) with sublobar resection and brachytherapy (radiation seed implants) on lung cancer.

Qualifications:

  • Must be at least 18 year of age
  • Must have a suspicious lung nodule for stage I NSCLC
  • Must have a mass no more than 3 cm diameter based on CT scan
  • Must not have had previous intra-thoracic radiation therapy
  • Women able to have children must have a negative pregnancy test

How to sign up: Call (513) 584-7698 or (888) 724-5959.

 

 

Topic:  Lung Cancer

 

Title:  CTSU E1505, A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB-IIIA Non-Small Lung Cancer (NSCLC)

 

Trial Dates:  Ongoing

 

Place:  The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center

 

Overview:  Drugs used in chemotherapy work in different ways to