Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases

Date de début de l'étude : 1 mai 2003

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