Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate
OBJECTIVES:
- Determine the progression-free and overall survival in patients with high-risk
metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide,
and paclitaxel with combined androgen-blockade therapy.
- Determine the type, frequency, and severity of toxicity of this regimen in this patient
population.
OUTLINE: This is a multicenter study.
- Androgen-blockade therapy: Patients receive a standard regimen of luteinizing
hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously
once monthly or once every 3 months or leuprolide intramuscularly once monthly, once
every 3 months, or once every 4 months. Patients also receive a standard regimen of
antiandrogen therapy comprising oral bicalutamide, oral flutamide, or oral nilutamide
once daily. Treatment continues in the absence of disease progression or unacceptable
toxicity.
- Chemotherapy: Beginning 14-30 days after initiation of androgen-blockade therapy,
patients receive oral estramustine three times daily and oral etoposide once daily on
days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
David C. Smith, MD
Study Chair
University of Michigan Cancer Center
United States: Federal Government
CDR0000069132
NCT00028769
December 2001
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Harrington Cancer Center | Amarillo, Texas 79106 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Puget Sound Oncology Consortium | Seattle, Washington 98109 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
Texas Tech University Health Sciences Center School of Medicine | Amarillo, Texas 79106 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Veterans Affairs Medical Center - Little Rock | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis, Tennessee 38104 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Western New York Urology Associates | Buffalo, New York 14220 |
Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |