A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy
OBJECTIVES:
- Compare overall survival of patients with platinum-sensitive recurrent ovarian
epithelial or primary peritoneal cancer treated with carboplatin with or without
pegylated doxorubicin HCl liposome.
- Compare progression-free survival, confirmed complete response rates, and time to
treatment failure in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease measurability (elevated CA 125 only vs nonmeasurable disease only with or without
elevated CA 125 vs measurable disease), number of disease sites (2 or fewer vs 3 or more),
and serous tumor histology (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl
liposome IV over 1 hour on day 1.
- Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats
every 4 weeks for a total of 15 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 4 weeks, every 6 months for 3 years, and then annually for 7 years.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 4 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
From date of registration to date of death
ten years
No
David S. Alberts, MD
Study Chair
University of Arizona
United States: Federal Government
CDR0000256331
NCT00043082
August 2002
July 2011
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
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 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
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 |
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
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 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
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 - Portland | Portland, Oregon 97207 |
Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
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 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
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 |
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 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
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 |
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 - Loma Linda (Pettis) | Loma Linda, California 92357 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
Providence Cancer Institute at Providence Hospital - Southfield | Southfield, Michigan 48075 |
University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis, Tennessee 38104 |
California Cancer Center at Woodward Park Office | Fresno, California 93720 |