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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00027859 |
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Drug: estramustine phosphate sodium Drug: ketoconazole Drug: therapeutic hydrocortisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and then annually for up to 10 years or until beginning of first non-protocol therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients previously treated with antiandrogen or glucocorticoid therapy must meet the following criteria:
Must show a continued rise in PSA after stopping antiandrogen (flutamide, bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)
Testosterone less than 50 ng/dL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Nirmala Bhoopalam, MD | Veterans Affairs Medical Center - Hines |
Investigator: | Gregory P. Swanson, MD | Deaconess Medical Center, Spokane, Washington |
Study Chair: | William Dahut, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000069088, ECOG-E1899, SWOG-E1899, CALGB-E1899 |
Study First Received: | December 7, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00027859 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage III prostate cancer |
Hydrocortisone Genital Neoplasms, Male Prostatic Diseases Cortisol succinate Clotrimazole Miconazole Estramustine Tioconazole Disease Progression |
Urogenital Neoplasms Genital Diseases, Male Ketoconazole Docetaxel Paclitaxel Hydrocortisone acetate Adenocarcinoma Prostatic Neoplasms |
Anti-Inflammatory Agents Anti-Infective Agents Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |
Antineoplastic Agents Antifungal Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |