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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: estramustine phosphate sodium Drug: flutamide Drug: ketoconazole Drug: nilutamide Drug: therapeutic hydrocortisone Drug: vinblastine Procedure: conventional surgery Procedure: endocrine drug therapy |
Phase III |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| 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.
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 | |||||
| M.D. Anderson Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Randall E. Millikan, MD, PhD | M.D. Anderson Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000065105, MDA-DM-95231, NCI-G96-1044 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002855 |
| Health Authority: | United States: Federal Government |
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