Prostate Cancer Clinical Trial
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases.
PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases.
Full Description
OBJECTIVES:
Primary
Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate.
Secondary
Compare the response rates in patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.
Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to hemoglobin (< 11g/dL vs ≥ 11 g/dL), alkaline phosphatase (normal vs elevated), number of prior regimens (0 vs 1 or 2), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive docetaxel IV on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-43.
Arm II: Patients receive docetaxel as in arm I and oral placebo once daily on days 1-43.
In both arms, courses repeat every 43 days in the absence of disease progression or unacceptable toxicity. Patients who progress on arm II may cross over to arm I.
PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study.
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
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There are 3 Locations for this study
Boston Massachusetts, 02115, United States
New York New York, 10021, United States
Houston Texas, 77030, United States
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