SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy Progressive disease defined by 1 of the following criteria: New bone scan lesions New or progressive radiologic lesions 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 all of the following: Continued treatment with an LHRH agonist or prior orchiectomy Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide) 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 75,000/mm^3 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 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
Sites / Locations
- Cancer Center and Beckman Research Institute, City of Hope
- USC/Norris Comprehensive Cancer Center and Hospital
- City of Hope Medical Group
- University of Illinois at Chicago
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Cancer Care Specialists of Central Illinois, S.C.
- Evanston Northwestern Health Care
- Ingalls Memorial Hospital
- LaGrange Memorial Hospital
- Loyola University Medical Center
- Division of Hematology/Oncology
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- Michiana Hematology/Oncology P.C.
- Oncology Care Associates, P.L.L.C.
- Veterans Affairs Medical Center - Durham
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm B
Arm A
dexamethasone followed by SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment if tumor grows.
SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment