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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| 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: Estramustine Phosphate Sodium Drug: Flutamide Drug: Ketoconazole Drug: Nilutamide Drug: Therapeutic Hydrocortisone Drug: Vinblastine Procedure: Conventional Surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate |
| Enrollment: | 306 |
| Study Start Date: | August 1996 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
|
Drug: Bicalutamide
Other Name: Casodex
Drug: Flutamide
Other Name: Eulexin
Drug: Nilutamide
Other Names:
Procedure: Conventional Surgery
Surgical castration
Other Name: Castration
|
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Experimental: Arm II
Arm II: Chemo/hormonal therapy for 3 x 8-week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks rest. Maintained on hydrocortisone both during treatment and during rest.
|
Drug: Doxorubicin hydrochloride
Other Names:
Drug: Estramustine Phosphate Sodium
Other Name: Emcyt
Drug: Ketoconazole
Other Name: Nizoral
Drug: Therapeutic Hydrocortisone
Other Names:
Drug: Vinblastine
Other Name: Velban
|
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Patients in arm II have a long-term central venous access device inserted.
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
| Responsible Party: | Millikan, Randall, M.D.,, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002855 History of Changes |
| Other Study ID Numbers: | DM95-231, P30CA016672, MDA-DM-95231, NCI-G96-1044, CDR0000065105 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Androgens Doxorubicin Nilutamide Bicalutamide |
Estramustine Flutamide Vinblastine Hydrocortisone acetate Cortisol succinate Hydrocortisone Ketoconazole Sodium phosphate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |