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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008

Conditions
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Metastatic Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Imatinib mesylate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel + Imatinib Mesylate<br>Docetaxel intravenous (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. | Drug: Docetaxel<br>* 30 mg/m^2 IV on days 1, 8, 15, and 22 every 42 days<br>Drug: Imatinib mesylate<br>* 600 mg orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy |  | 12 weeks after initiation of crossover therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | 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. | From registration to disease progression, up to 32 months | 
| Response rate |  | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases