NCT04503668

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
DRUG	Ondansetron	8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
DRUG	Dexamethasone	20 mg IV on day 1 pre-chemotherapy
DRUG	Neurokinin-1 Receptor Antagonist (NK1-RA)	150 mg IV on day 1 pre-chemotherapy
DRUG	Olanzapine	5 mg by mouth on days 1-4 of chemotherapy (taken at night)
DRUG	Compazine	5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Timeline

• Start date: 2020-12-28
• Primary completion: 2024-01-03
• Completion: 2024-03-11
• First posted: 2020-08-07
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study