Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases
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 * Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate. Secondary * Compare the response rates in patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to hemoglobin (< 11g/dL vs ≥ 11 g/dL), alkaline phosphatase (normal vs elevated), number of prior regimens (0 vs 1 or 2), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive docetaxel IV on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-43. * Arm II: Patients receive docetaxel as in arm I and oral placebo once daily on days 1-43. In both arms, courses repeat every 43 days in the absence of disease progression or unacceptable toxicity. Patients who progress on arm II may cross over to arm I. PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.116 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 confirmed by radiography * Lytic bone lesions considered for biopsy if there is clinical suspicion of histologic conversion to small cell carcinoma * Failed prior hormonal therapy * Progressive disease, as evidenced by one of the following: * 2 consecutive rises in prostate-specific antigen (PSA) of at least 1 ng/mL over 4 weeks * Increase of 25% of the product of bidimensional disease or 30% in maximum diameter * Increase in number of osseous metastases by bone scan * Worsening symptoms attributable to disease progression (e.g., worsening bony pain) * PSA ≥ 1 ng/mL * Castrate serum testosterone ≤ 50 ng/dL * Concurrent luteinizing-hormone releasing-hormone analog required for medically castrated patients * No small cell or sarcomatoid prostate cancers * No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age * Any age Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 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 myocardial infarction within the past 6 months * No evidence of myocardial ischemia on electrocardiogram * No uncontrolled severe hypertension Pulmonary * No oxygen-dependent lung disease Other * HIV negative * No concurrent severe infection * No contraindication to corticosteroids * No uncontrolled diabetes mellitus * No grade 2 or greater peripheral neuropathy * No other malignancy within the past 2 years except nonmelanoma skin cancer * No overt psychosis, mental disability, or incompetency that would preclude giving informed consent * No history of noncompliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior taxanes * No more than 2 prior chemotherapy regimens * At least 30 days since prior chemotherapy and recovered * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 4 weeks since prior flutamide or nilutamide\* * At least 6 weeks since prior bicalutamide\* NOTE: \*Unless there is evidence of interim disease progression Radiotherapy * At least 90 days since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium and recovered * At least 30 days since other prior radiotherapy and recovered Surgery * Fully recovered from prior surgery Other * No concurrent ketoconazole * No concurrent warfarin
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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