Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008
Metastatic Cancer, Prostate Cancer
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the prostate Osseous metastases Androgen-independent disease Previously randomized to the docetaxel and placebo arm of protocol MDA-ID-030008 and has been removed from protocol due to disease progression No more than 6 weeks since final treatment with docetaxel and placebo No uncontrolled brain metastases or spinal cord compression PATIENT CHARACTERISTICS: Age Any age Performance status Eastern Cooperative Oncology Group (ECOG) 0-3 Life expectancy Not specified Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 75,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2 times upper limit of normal No chronic liver disease Renal Creatinine clearance ≥ 40 mL/min Cardiovascular No New York Heart Association class III or IV congestive heart failure No unstable angina No uncontrolled severe hypertension No myocardial infarction within the past 6 months Pulmonary No oxygen-dependent lung disease Other No prior dose-limiting toxicity with docetaxel requiring more than 2 dose reductions No severe hypersensitivity to docetaxel No prior dose-limiting toxicity with docetaxel requiring 1 dose reduction AND experienced recurrent grade 3 or 4 toxicity at the time of progression on MDA-ID-030008 No uncontrolled diabetes mellitus No concurrent severe infection No overt psychosis, mental disability, or other incompetency that would preclude giving informed consent No history of non-compliance HIV negative Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy See Disease Characteristics No other concurrent chemotherapy Endocrine therapy No concurrent second-line hormonal therapy Radiotherapy At least 3 weeks since prior radiotherapy No recent strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery Recovered from prior surgery Other No other concurrent anticancer agents No other concurrent investigational agents No concurrent therapeutic warfarin Concurrent mini-dose warfarin (1 mg/day) for central venous catheter prophylaxis allowed No concurrent grapefruit or grapefruit juice
Sites / Locations
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- M.D. Anderson Cancer Center at University of Texas
Arms of the Study
Arm 1
Experimental
Docetaxel + Imatinib Mesylate
Docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-42. Courses repeat every 42 days.