Spots Global Cancer Trial Database for Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
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Trial Identification
Brief Title: Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Official Title: 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
Study ID: NCT00072215
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors. PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Northeast Alabama Regional Medical Center, Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States
Naval Medical Center - San Diego, San Diego, California, United States
Veterans Affairs Medical Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Baptist Hospital East - Louisville, Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord, Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cape Fear Valley Medical Center, Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Miriam Hospital at Lifespan, Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas, Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Vermont Cancer Center at University of Vermont, Burlington, Vermont, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, United States
St. Mary's Medical Center, Huntington, West Virginia, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: Robert J. Motzer, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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