A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors
OBJECTIVES:
Primary
- Compare the overall survival of men with progressive or recurrent metastatic germ cell
tumors treated with paclitaxel, ifosfamide, and cisplatin vs vinblastine, ifosfamide,
and cisplatin as second-line therapy.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxicity profiles of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
complete response or partial response with negative markers for at least 6 months (yes vs
no) and relapse at least 2 years after completing first-line chemotherapy for germ cell
tumors (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over
20-30 minutes and ifosfamide IV over 30 minutes on days 2-5. Patients also receive
filgrastim (G-CSF) subcutaneously (SC) on days 7-18 OR pegfilgrastim SC once within
24-72 hours after completion of chemotherapy.
- Arm II: Patients receive vinblastine IV on days 1 and 2 and cisplatin IV over 20-30
minutes and ifosfamide IV over 30 minutes on days 1-5. Patients also receive G-CSF SC
on days 7-18 OR pegfilgrastim as in arm I.
In both arms, treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months
for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this
study within 5.5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
2 months
No
Robert J. Motzer, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000339340
NCT00072215
April 2004
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
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 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
St. Mary's Medical Center | Huntington, West Virginia 25701 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
NorthEast Oncology Associates - Concord | Concord, North Carolina 28025 |
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | Roanoke, Virginia 24014 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Cape Fear Valley Medical Center | Fayetteville, North Carolina 28302-2000 |
Comprehensive Cancer Center at Moore Regional Hospital | Pinehurst, North Carolina 28374 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
Miriam Hospital at Lifespan | Providence, Rhode Island 02906 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Palm Beach Cancer Institute - West Palm Beach | West Palm Beach, Florida 33401 |