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: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgens; Docetaxel; Imatinib Mesylate

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