Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
Docetaxel
+ Imatinib mesylate
Urogenital Diseases+10
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: May 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, United StatesSee the locationMemorial Sloan-Kettering Cancer Center
New York, United StatesM.D. Anderson Cancer Center at University of Texas
Houston, United States