Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
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 confirmed by radiography Lytic bone lesions considered for biopsy if there is clinical suspicion of histologic conversion to small cell carcinoma Failed prior hormonal therapy Progressive disease, as evidenced by one of the following: 2 consecutive rises in prostate-specific antigen (PSA) of at least 1 ng/mL over 4 weeks Increase of 25% of the product of bidimensional disease or 30% in maximum diameter Increase in number of osseous metastases by bone scan Worsening symptoms attributable to disease progression (e.g., worsening bony pain) PSA ≥ 1 ng/mL Castrate serum testosterone ≤ 50 ng/dL Concurrent luteinizing-hormone releasing-hormone analog required for medically castrated patients No small cell or sarcomatoid prostate cancers No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age Any age Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy At least 3 months Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 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 myocardial infarction within the past 6 months No evidence of myocardial ischemia on electrocardiogram No uncontrolled severe hypertension Pulmonary No oxygen-dependent lung disease Other HIV negative No concurrent severe infection No contraindication to corticosteroids No uncontrolled diabetes mellitus No grade 2 or greater peripheral neuropathy No other malignancy within the past 2 years except nonmelanoma skin cancer No overt psychosis, mental disability, or incompetency that would preclude giving informed consent No history of noncompliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy No prior taxanes No more than 2 prior chemotherapy regimens At least 30 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy See Disease Characteristics At least 4 weeks since prior flutamide or nilutamide* At least 6 weeks since prior bicalutamide* NOTE: *Unless there is evidence of interim disease progression Radiotherapy At least 90 days since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium and recovered At least 30 days since other prior radiotherapy and recovered Surgery Fully recovered from prior surgery Other No concurrent ketoconazole No concurrent warfarin
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
Arm 2
Experimental
Placebo Comparator
Docetaxel + Imatinib Mesylate
Docetaxel + Placebo
Docetaxel 30 mg/m^2 intravenous over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral 600 mg imatinib mesylate.
Docetaxel 30 mg/m^2 intravenous (IV) over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral placebo.