Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell transplant is more effective than chemotherapy alone. PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works when given with peripheral stem cell transplant and how it compares with combination chemotherapy alone in treating men with previously untreated germ cell cancer.

Timeline

Start

1999-04

Primary completion

2007-06

Completion

—

Outcome

Missed primary endpoint

paper There was no difference in FFS between the two treatment arms (P = 0.057, 66 events). PMID 21059637 ↗

paper CONCLUSION: This study could not demonstrate that high-dose chemotherapy given as part of first-line therapy improves outcome in patients with poor-prognosis GCC. PMID 21059637 ↗

Publications

• Results Daugaard G, Skoneczna I, Aass N, De Wit R, De Santis M, Dumez H, Marreaud S, Collette L, Lluch JRG, Bokemeyer C, Schmoll HJ. A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). Ann Oncol. 2011 May;22(5):1054-1061. doi: 10.1093/annonc/mdq575. Epub 2010 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bleomycin	Unknown	—	Intravenous
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	Etoposide	Small molecule	—	Intravenous
Subject	Ifosfamide	Small molecule	—	Intravenous
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous

Indications