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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B North Central Cancer Treatment Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004001 |
RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Drug: estramustine phosphate sodium Drug: mitoxantrone hydrochloride Drug: prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 620 |
Study Start Date: | October 1999 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after randomization.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study within 3.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria:
Medical castration using leuprolide or goserelin
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, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Minnesota | |
CentraCare Health Plaza | |
Saint Cloud, Minnesota, United States, 56303 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68106 | |
United States, North Dakota | |
Altru Health System | |
Grand Forks, North Dakota, United States, 58201 | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
Medcenter One Health System | |
Bismarck, North Dakota, United States, 58501 | |
United States, Pennsylvania | |
CCOP - Geisinger Clinic and Medical Center | |
Danville, Pennsylvania, United States, 17822-2001 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57104 | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 |
Study Chair: | Daniel P. Petrylak, MD | Herbert Irving Comprehensive Cancer Center |
Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study Chair: | Patrick A. Burch, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067211, SWOG-S9916, CLB-99808, NCCTG-S9916 |
Study First Received: | November 1, 1999 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00004001 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Anti-Inflammatory Agents Prednisone Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Estramustine Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male Glucocorticoids |
Hormones Recurrence Docetaxel Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Mitoxantrone Adenocarcinoma Alkylating Agents Prostatic Neoplasms |
Anti-Inflammatory Agents Prednisone Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Estramustine Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Hormones Docetaxel Neoplasms by Site Sensory System Agents |
Therapeutic Uses Analgesics Alkylating Agents Antineoplastic Agents, Hormonal Genital Diseases, Male Glucocorticoids Pharmacologic Actions Neoplasms Mitoxantrone Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Prostatic Neoplasms Central Nervous System Agents |