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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005847 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which treatment regimen is more effective in treating metastatic prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with that of chemotherapy plus biological therapy in treating patients who have progressive or metastatic prostate cancer that has not responded to hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Biological: recombinant interferon alfa Drug: estramustine phosphate sodium Drug: isotretinoin Drug: mitoxantrone hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Trial of Mitoxantrone, Estramustine and Navelbine or 13-Cis Retinoic Acid, Interferon and Paclitaxel in Patients With Metatstatic Hormone Refractory Prostate Cancer |
Study Start Date: | January 2001 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (measurable vs nonmeasurable and elevated PSA). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, on day 2 of courses 2, 4, and 6 (arm I), on day 22 of course 1 and day 1 of courses 2 and 3 (arm II), and then at completion of treatment.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70-114 patients (35-57 per arm) will be accrued for this study within 14-23 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Colorado | |
CCOP - Colorado Cancer Research Program, Incorporated | |
Denver, Colorado, United States, 80224 | |
United States, Georgia | |
Emory University Hospital - Atlanta | |
Atlanta, Georgia, United States, 30322 | |
Veterans Affairs Medical Center - Atlanta (Decatur) | |
Decatur, Georgia, United States, 30033 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
United States, Massachusetts | |
Tufts - New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
CCOP - Kalamazoo | |
Kalamazoo, Michigan, United States, 49007-3731 | |
United States, Minnesota | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
CCOP - Northern New Jersey | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
MBCCOP-Our Lady of Mercy Cancer Center | |
Bronx, New York, United States, 10466 | |
United States, North Dakota | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
United States, Ohio | |
CCOP - Toledo Community Hospital | |
Toledo, Ohio, United States, 43623-3456 | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Pennsylvania | |
CCOP - Geisinger Clinic and Medical Center | |
Danville, Pennsylvania, United States, 17822-2001 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57104 | |
United States, Wisconsin | |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
Green Bay, Wisconsin, United States, 54307-3453 | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226-3596 |
Study Chair: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
Investigator: | Robert G. Kilbourn, MD, PhD | Southwest Regional Cancer Center - San Marcos |
Study ID Numbers: | CDR0000067865, E-3899 |
Study First Received: | June 2, 2000 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00005847 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Interferon Type I, Recombinant Prostatic Diseases Genital Neoplasms, Male Immunologic Factors Estramustine Urogenital Neoplasms Vinblastine Hormones Isotretinoin Analgesics Alkylating Agents Interferon-alpha Antineoplastic Agents, Hormonal Interferons Antimitotic Agents |
Genital Diseases, Male Antiviral Agents Angiogenesis Inhibitors Recurrence Vinorelbine Paclitaxel Tubulin Modulators Tretinoin Peripheral Nervous System Agents Mitoxantrone Antineoplastic Agents, Alkylating Interferon Alfa-2a Adenocarcinoma Antineoplastic Agents, Phytogenic Prostatic Neoplasms |
Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Prostatic Diseases Genital Neoplasms, Male Immunologic Factors Antineoplastic Agents Estramustine Physiological Effects of Drugs Urogenital Neoplasms Vinblastine Neoplasms by Site Sensory System Agents Therapeutic Uses Isotretinoin |
Analgesics Growth Inhibitors Angiogenesis Modulating Agents Dermatologic Agents Alkylating Agents Interferon-alpha Antineoplastic Agents, Hormonal Growth Substances Mitosis Modulators Interferons Antimitotic Agents Genital Diseases, Male Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions |