drugset
drugset / Trial / NCT02116530

Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

NCT02116530 ↗

Phase 3 Completed 401 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindSupportive care

Summary

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

Timeline

Start
2014-08-20
Primary completion
2015-04-04
Completion
2017-06-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 10 mg Oral
Background Aprepitant Other / unclassified 80 mg Oral
Background Cisplatin Other / unclassified 70 mg/m2 —
Background Cyclophosphamide Other / unclassified — —
Background Dexamethasone Small molecule 8 mg Oral
Background Doxorubicin Other / unclassified — —
Background Fosaprepitant Other / unclassified 150 mg Intravenous
Background Granisetron Other / unclassified 1 mg Intravenous
Background Granisetron Other / unclassified 2 mg Intravenous
Background Ondansetron Other / unclassified 8 mg Oral
Background Palonosetron Other / unclassified 0.25 mg Intravenous

Indications

cancer of unknown primary site hematopoietic and lymphoid cell neoplasm