A RANDOMIZED, CONTROLLED TRIAL OF SALVAGE THERAPY WITH PACLITAXEL AND CARBOPLATIN VERSU SALVAGE THERAPY WITH STEM CELL SUPPORTED HIGH-DOSE CARBOPLATIN, MITOXANTRONE AND CYCLOPHOSPHAMIDE IN PATIENTS WITH PERSISTENT LOW VOLUME OVARIAN CANCER AND RESPONSE TO PRIMARY THERAPY
OBJECTIVES: I. Compare progression-free and overall survival of patients with
drug-sensitive, low-volume ovarian cancer that is persistent following standard therapy
treated with salvage therapy comprising standard-dose paclitaxel and carboplatin vs
high-dose carboplatin, mitoxantrone, and cyclophosphamide followed by bone marrow
reconstitution. II. Compare the toxic effects of these two salvage regimens. III. Compare
selected health-related aspects of quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center and disease state at reassessment laparotomy. Patients are randomized to one of two
treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and carboplatin
IV continuously on days 1-5 every 3 weeks for a total of 6 courses. Arm II: Patients receive
cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4,
and carboplatin IV continuously on days -8 through -4, followed by rescue with autologous
bone marrow or peripheral blood stem cells on day 0. Quality of life is assessed at
baseline, at 3 and 9 weeks after starting treatment, and every 3 months for an additional 5
assessments regardless of disease progression.
PROJECTED ACCRUAL: A total of 275 patients will be accrued over approximately 60 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
William P. McGuire, MD
Study Chair
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
United States: Federal Government
CDR0000064983
NCT00002819
November 1996
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |