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QL05-37

Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen

For full description, see www.clinicaltrials.gov.

Abstracts/Posters/Presentations:

  • M.J. Brames, E. Johnston, C.R. Nichols, J. Picus, D.J. Vaughn, C.A. Fausel, T.E. Breen, M. Yu, and L.H. Einhorn. Phase III double blind placebo controlled crossover study evaluating a 5HT3 antagonist + dexamethasone +/- aprepitant in germ cell tumor patients receiving 5 day cisplatin combination chemotherapy. A Hoosier Oncology Group study QL05-37. Accepted as a Poster Presentation at the International Symposium of the Multinational Association of Supportive Care in Cancer, June 24-26, 2010 Vancouver, Canada.
  • M.J. Brames, J. Picus, M. Yu, E. Johnston, B. Bottema, C. Williams, and L.H. Einhorn. Phase III double blind placebo controlled crossover study evaluating a 5HT3 antagonist + dexamethasone +/- aprepitant in germ cell tumor patients receiving 5 day cisplatin combination chemotherapy. A Hoosier Oncology Group study QL05-37. Accepted as an Oral Presentation at the Oral Abstract Session (Abstract # 9013) at the ASCO Annual Meeting, June 4-8 2011, Chicago, IL.
  • M.J. Brames, J. Picus, M. Yu, E. Johnston, B. Bottema, C. Williams, and L.H. Einhorn. Phase III double blind placebo controlled crossover study evaluating a 5HT3 antagonist + dexamethasone +/- aprepitant in germ cell tumor patients receiving 5 day cisplatin combination chemotherapy. A Hoosier Oncology Group study QL05-37. Accepted as an Oral Presentation (Abstract # A-327-0011-00199) to the 2011 International Symposium of the Multinational Association of Supportive Care in Cancer, June 23-25, Athens, Greece.

Manuscripts/Articles:

  • Einhorn LH, Brames MJ, Dreicer R, Nichols CR, Cullen MT Jr, Bubalo J. Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer. Hoosier Oncology Group Study QL05-37. Support Care Center 2007 Nov; 15(11): 1293-300.
  • Albany C, Brames MJ, Fausel C, Johnson CS, Picus J, Einhorn LH. Randomized, Double-Blind, Placebo-Controlled, Phase III Cross-Over Study Evaluating the Oral Neurokinin-1 Antagonist Aprepitant in Combination With a 5HT3 Receptor Antagonist and Dexamethasone in Patients With Germ Cell Tumors Receiving 5-Day Cisplatin Combination Chemotherapy Regimens: A Hoosier Oncology Group Study QL05-37. J Clin Oncol. 2012 Nov 10;30(32):3998-4003. doi: 10.1200/JCO.2011.39.5558. Epub 2012 Aug 2