Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy

Major Program(s) or Research Group(s)

  • Community Oncology and Prevention Trials
  • NCI Community Oncology Research Program
  • Supportive Care and Symptom Management

Sponsor

Alliance for Clinical Trials in Oncology

Status

Recruiting

ClinicalTrials.gov ID

For more information, see ClinicalTrials.gov NCT03578081

This randomized phase III trial studies how well olanzapine with or without fosaprepitant
work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving
chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control
nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in
combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if
olanzapine when given with other drugs, is still effective without using fosaprepitant
dimeglumine for controlling nausea and vomiting.

Intervention

Palonosetron Hydrochloride, Ondansetron Hydrochloride, Dexamethasone, Fosaprepitant Dimeglumine, Olanzapine, Placebo

Condition

Malignant Neoplasm

Investigators

Rudolph Navari, MD, PhD, FACP, Jeffrey L. Berenberg, Elie G. Dib, Daniel M. Anderson, Richard F. Gorman, Howard M. Gross, Steven Ades, Bryan A. Faller, Jeffrey K. Giguere, Jay W. Carlson, Kathryn J. Ruddy, Thomas J. Reid, Demet Gokalp Yasar, David S. Hanson, Anthony J. Jaslowski, Robert J. Behrens, James H. Feusner, Srilatha B. Hosur, Preston D. Steen, Maria T. Grosse-Perdekamp, Jeffrey J. Kirshner, Shaker R. Dakhil, Deborah W. Wilbur, Arvinder S. Bir, Maria R. Tria Tirona, Kelvin B. Raybon, Jeremy G. Perkins, Kathleen J. Yost, Thomas J. Saphner, Qiwei W. Gai, Philip A. Lowry, Donald F. Busiek, Praveen Vikas, Scott T. Tagawa, Grant R. Seeger, Lauren A. Wiebe, Sharon D. Luikart, Debra M. Prow, Scott M. Lindhorst, Andy Y. Huang, John M. Schallenkamp, Abhishek Tripathi, Shylendra B. Sreenivasappa, Serge Dauphin, Christopher M. George, Sunitha Vemulapalli, Wei Song, Pankaj Gupta, Kevin P. Ridenhour, Amy L. Curran, John J. Inzerillo, Donald J. Jurgens, Nicholas DiBella, David E. Einspahr, Ravneet Thind, Kimberly W. Schlesinger, Srikanth Tamma, Scott Brook, Kristina Goutsouliak, Prabhjot S. Mundi, Geetika Kumar, Natalie Harper, Charles A. Leath, Alexander R. Quesenberry, Mukund Nadipuram, Nisar Ahmad, Bolanle Gbadamosi, John A. Ellerton, Barry R. Meisenberg, Ruby Sharma, Jorge G. Darcourt

See list of participating sites