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

Summary

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.

Timeline

Start

2018-11-20

Primary completion

2021-11-08

Completion

2023-05-01

Outcome

Missed primary endpoint

paper The proportion of patients without nausea for the complete 5-day study period was 7.4% lower (upper limit of the one-sided 95% confidence interval was 13.5%) PMID 37284847 ↗

paper This trial did not provide sufficient evidence to support that deletion of the NK-1 receptor antagonist was as good as keeping it PMID 37284847 ↗

Publications

• Navari RM, Le-Rademacher J, Smieliauskas F, Ruddy KJ, James Saphner T, Liu H, Harlos E, Onitilo AA, Giridhar K, Paul Singh P, Reddy PS, Chow S, Kruter F, Raptis G, Loprinzi CL. Olanzapine With or Without Fosaprepitant for Preventing Chemotherapy Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial (ALLIANCE A221602). Oncologist. 2023 Aug 3;28(8):722-729. doi: 10.1093/oncolo/oyad140.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fosaprepitant	Other / unclassified	150 mg	Intravenous
Subject	Olanzapine	Small molecule	—	Oral
Background	Dexamethasone	Small molecule	—	Oral
Background	Ondansetron	Other / unclassified	—	Intravenous
Background	Palonosetron	Other / unclassified	—	Intravenous

Indications