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Brief Title: Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors
Official Title: Randomized Phase II Trial of Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-Risk Germ Cell Tumors
Study ID: NCT01873326
Brief Summary: The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Southern California, Los Angeles, California, United States
Stanford University Medical Center, Stanford, California, United States
University of Chicago, Chicago, Illinois, United States
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Follow-up Only), Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Name: Darren Feldman, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR