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
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Diagnosis of adenocarcinoma of the prostate
- Osseous metastases
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Androgen-independent disease
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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
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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
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No other concurrent anticancer agents
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No other concurrent investigational agents
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No concurrent therapeutic warfarin
- Concurrent mini-dose warfarin (1 mg/day) for central venous catheter prophylaxis allowed
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No concurrent grapefruit or grapefruit juice
Trial design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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