Prostate Cancer Clinical Trial
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
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. Giving docetaxel with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.
Full Description
OBJECTIVES:
Primary
Provide treatment with docetaxel and imatinib mesylate for patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and placebo on MDA-ID-030008.
Secondary
Determine the response rate and time to progression in these patients after crossover from docetaxel and placebo to docetaxel and imatinib mesylate.
Compare the modulation of the platelet-derived growth factor receptor pathway by docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient.
Determine the quality of life of patients treated with this crossover regimen.
OUTLINE: This is an open-label, crossover, multicenter, extension study. Patients who progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel and imatinib mesylate.
Patients receive docetaxel 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 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each therapy course, and at the completion of therapy.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.
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
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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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