A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
OBJECTIVES:
- Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine,
doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free
survival, in patients with stage III or IV ovarian epithelial or serous primary
peritoneal carcinoma.
- Determine the response rate in patients with measurable disease treated with these
regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the complications in patients treated with these regimens.
- Determine the dose-intensity and cumulative dose delivery for these regimens in these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata
according to extent of residual disease and plans for interval cytoreductive surgery:
- Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for
surgery
- Stratum B: Suboptimal residual disease without plans for surgery
- Stratum C: Suboptimal residual disease with plans for surgery Patients are randomized
to 1 of 5 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on
days 1 and 8. Treatment continues as in arm I.
- Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin
HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues
as in arm I.
- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV
over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients
then receive 4 courses of arm I chemotherapy.
- Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin
IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients
then receive 4 courses of arm I chemotherapy.
Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may
undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months.
PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be
accrued for this study within 3.5-5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Michael A. Bookman, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000068467
NCT00011986
January 2001
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Tacoma General Hospital | Tacoma, Washington 98405 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
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 - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
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 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
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 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
CCOP - Evanston | Evanston, Illinois 60201 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Southeast Gynecologic Oncology Associates | Knoxville, Tennessee 37917 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
North Shore University Hospital | Manhasset, New York 11030 |
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 - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
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 - Houston | Houston, Texas 77030 |
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 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Cooper University Hospital | Camden, New Jersey 08103 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
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 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Veterans Affairs Medical Center - Salisbury | Salisbury, North Carolina 28144 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Cancer Center at Lexington Clinic | Lexington, Kentucky 40504 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Arthur G. James Cancer Hospital at Ohio State University | Columbus, Ohio 43210-1240 |
Gynecologic Oncology Network | Nashville, Tennessee 37203 |
Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Providence Cancer Institute at Providence Hospital | Southfield, Michigan 48075 |
Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital) | Hines, Illinois 60141 |