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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002855 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: doxorubicin hydrochloride Drug: endocrine drug therapy Drug: estramustine phosphate sodium Drug: flutamide Drug: ketoconazole Drug: nilutamide Drug: therapeutic hydrocortisone Drug: vinblastine Procedure: conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A PHASE 3 TRIAL OF ANDROGEN ABLATION ALONE VS. CHEMO/HORMONAL THERAPY AS INITIAL TREATMENT OF UNRESECTABLE/METASTATIC ADENOCARCINOMA OF THE PROSTATE |
| Estimated Enrollment: | 368 |
| Study Start Date: | August 1996 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Randall E. Millikan, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065105, MDA-DM-95231, NCI-G96-1044 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002855 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
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Anti-Inflammatory Agents Hydrocortisone Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Estramustine Hormones, Hormone Substitutes, and Hormone Antagonists Vinblastine Urogenital Neoplasms Flutamide Hormones Anti-Bacterial Agents Antifungal Agents Alkylating Agents Cortisol succinate |
Antineoplastic Agents, Hormonal Nilutamide Antimitotic Agents Ketoconazole Genital Diseases, Male Doxorubicin Recurrence Androgen Antagonists Tubulin Modulators Bicalutamide Hydrocortisone acetate Antineoplastic Agents, Alkylating Adenocarcinoma Antineoplastic Agents, Phytogenic Prostatic Neoplasms |
|
Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Estramustine Hormones, Hormone Substitutes, and Hormone Antagonists Vinblastine Urogenital Neoplasms Antibiotics, Antineoplastic Neoplasms by Site |
Antifungal Agents Therapeutic Uses Alkylating Agents Cortisol succinate Antineoplastic Agents, Hormonal Nilutamide Mitosis Modulators Antimitotic Agents Genital Diseases, Male Ketoconazole Doxorubicin Pharmacologic Actions Androgen Antagonists Neoplasms Tubulin Modulators |