Status:
COMPLETED
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
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
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 bl...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00084825
Start Date
May 1 2003
End Date
June 1 2008
Last Update
October 26 2012
Active Locations (3)
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1
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
3
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009