- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00080678
Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases
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. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases.
PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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-
Texas
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Houston, Texas, United States, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel + Imatinib Mesylate
Docetaxel 30 mg/m^2 intravenous over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral 600 mg imatinib mesylate.
|
Other Names:
Other Names:
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Placebo Comparator: Docetaxel + Placebo
Docetaxel 30 mg/m^2 intravenous (IV) over 60 minutes on days 1, 8, 15, and 22 in 42-day cycles, with daily oral placebo.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression
Time Frame: Baseline to 3 years, or until disease progression
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Baseline to 3 years, or until disease progression
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: Up to 3 years
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Up to 3 years
|
Toxic effects
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Paul Mathew, M.D. Anderson Cancer Center
- Study Chair: Christopher Logothetis, MD, M.D. Anderson Cancer Center
Publications and helpful links
General Publications
- Mathew P, Thall PF, Johnson MM, et al.: Preliminary results of a randomized placebo-controlled double-blind trial of weekly docetaxel combined with imatinib in men with metastatic androgen-independent prostate cancer (AIPC) and bone metastases (BM). [Abstract] J Clin Oncol 24 (Suppl 18): A-4562, 232s, 2006.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Neoplastic Processes
- Prostatic Neoplasms
- Neoplasm Metastasis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protein Kinase Inhibitors
- Docetaxel
- Imatinib Mesylate
Other Study ID Numbers
- CDR0000354505
- MDA-ID-030008
- NOVARTIS-MDA-ID-030008
- MSKCC-03132
- DFCI-03187
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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