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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028769 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: estramustine phosphate sodium Drug: etoposide Drug: flutamide Drug: goserelin Drug: leuprolide acetate Drug: nilutamide Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastic Adenocarinoma of the Prostate |
| Study Start Date: | December 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
Clinical stage D2 disease as evidenced by one of the following:
No prior or concurrent (treated or untreated) brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36607 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Veterans Affairs Medical Center - Tampa (Haley) | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5500 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Chicago Westside Hospital | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Hines | |
| Hines, Illinois, United States, 60141 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7390 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Cancer Center at Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71101-4295 | |
| United States, Massachusetts | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| Josephine Ford Cancer Center at Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | |
| Southfield, Michigan, United States, 48075 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0946 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| Saint Louis University Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Western New York Urology Associates | |
| Cheektowaga, New York, United States, 14225 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428-1002 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97201-3098 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute at Methodist Central Hospital | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| UMC Southwest Cancer and Research Center | |
| Lubbock, Texas, United States, 79415-3364 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4095 | |
| Texas Tech University Health Sciences Center School of Medicine | |
| Amarillo, Texas, United States, 79106 | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| Veterans Affairs Medical Center - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Virginia | |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23510-1115 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| Study Chair: | David C. Smith, MD | University of Michigan Cancer Center |
More Information
| Study ID Numbers: | CDR0000069132, SWOG-S0032 |
| Study First Received: | January 4, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028769 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Estramustine Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Flutamide Etoposide phosphate Neoplasms by Site Leuprolide Therapeutic Uses |
Etoposide Alkylating Agents Antineoplastic Agents, Hormonal Nilutamide Mitosis Modulators Goserelin Antimitotic Agents Genital Diseases, Male Pharmacologic Actions Neoplasms Androgen Antagonists Paclitaxel Fertility Agents, Female Tubulin Modulators Fertility Agents |