Metastatic Cancer, Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases
Brief 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.
Detailed 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.
Interventions
DRUGDocetaxel
30 mg/m\^2 IV on days 1, 8, 15, and 22 every 42 days
DRUGImatinib mesylate
600 mg orally daily
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment efficacy | 12 weeks after initiation of crossover therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | From registration to disease progression, up to 32 months | Time of progression was defined as the time of appearance of symptoms attributable to disease progression, the first demonstrated clinical sign or radiological evidence of disease progression, or the time of first of consecutive prostate-specific antigen (PSA) increments that achieved 25% increase over baseline or nadir (or death during the study), whichever was earliest. |
| Response rate | Up to 3 years | — |
Countries
United States
Outcome results
None listed