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SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Human subjects often receive the most effective healthcare possible for their SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy  SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: recurrent prostate cancer,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor. Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet known whether SU5416 or dexamethasone is more effective in treating progressive prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of dexamethasone in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Compare the time to progression in patients with hormone refractory prostate cancer treated with dexamethasone with or without SU5416. II. Determine the differences in PSA kinetics and PSA hazard score between these two regimens in this patient population. III. Determine the objective response rate and time to development of new lesions in these patients treated with SU5416. IV. Determine the toxicity of SU5416 in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral dexamethasone once a day 6 days a week. Treatment continues until disease progression, at which time patients cross over to arm II. Arm II: Patients receive oral dexamethasone as in arm I followed by SU5416 IV over 60 minutes twice weekly for 4 weeks. A smaller dose of dexamethasone is administered the day after SU5416. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy - Progressive disease defined by: New bone scan lesions OR New or progressive radiologic lesions OR Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL - Progressive disease, as defined above, despite adequate hormonal therapy defined by: Continued treatment with an LHRH agonist or prior orchiectomy AND Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide) AND Trial of antiandrogen withdrawal at least 4 weeks prior to study - CNS metastasis allowed if: Previously treated; Neurologically stable; Oral or intravenous steroids or anticonvulsants not required; Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease; Negative brain scan required if neurologic signs or symptoms suggestive of CNS metastasis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior systemic chemotherapy; No other concurrent chemotherapy; No other concurrent investigational antineoplastic drugs - Endocrine therapy: See Disease Characteristics - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 4 weeks since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No uncompensated coronary artery disease; No history of myocardial infarction or severe unstable angina within the past 6 months; No severe peripheral vascular disease associated with diabetes mellitus; No deep venous or arterial thrombosis within the past 3 months - Pulmonary: No pulmonary embolism within the past 3 months - Other: Not pregnant; Fertile patients must use effective contraception; No significant uncontrolled underlying medical or psychiatric illness; No serious active infection; No other prior or concurrent malignancy except nonmelanoma skin cancer unless completed therapy and considered to be at less than 30% risk of relapse; No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, University of Chicago Cancer Research Center
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
City of Hope Medical Group
Pasadena, California, 91105
United States
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Additional Information:
Study ID Numbers: CDR0000068010; UCCRC-10428,NCI-49,UCCRC-NCI-49
Study Start Date: June 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006002
Other Stage 4 Prostate Cancer Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
2. Biological Therapy in Treating Patients With Prostate Cancer
3. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
4. Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
5. Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
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SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
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