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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080678 |
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.
Condition | Intervention | Phase |
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Metastatic Cancer Prostate Cancer |
Drug: docetaxel Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases |
Estimated Enrollment: | 152 |
Study Start Date: | May 2003 |
OBJECTIVES:
Primary
Secondary
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.
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the prostate
Progressive disease, as evidenced by one of the following:
Castrate serum testosterone ≤ 50 ng/dL
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Paul Mathew | M.D. Anderson Cancer Center |
Investigator: | Christopher Logothetis, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000354505, MDA-ID-030008, NOVARTIS-MDA-ID-030008, MSKCC-03132, DFCI-03187 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00080678 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer bone metastases |
Imatinib Docetaxel Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Protein Kinase Inhibitors Prostatic Neoplasms Recurrence Androgens |
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Protein Kinase Inhibitors Pharmacologic Actions |
Docetaxel Imatinib Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasm Metastasis Prostatic Neoplasms |