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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Rogel Cancer Center
• Treatments: Dexamethasone; Fosaprepitant; Neurokinin-1 Receptor Antagonists; Olanzapine; Ondansetron; Prochlorperazine

Criteria

Inclusion Criteria:

• Diagnosis of gynecologic malignancy

• No chemotherapy in the last 12 months

• Scheduled to receive Carboplatin (AUC>=4) and Paclitaxel every three weeks

• ECOG performance status 0 or 1

• English speaking

• Willing and able to provide informed consent

• Laboratory values within protocol-defined parameters

• No vomiting in the 24 hours prior to initiating chemotherapy

• If childbearing potential exists, negative pregnancy test within 7 days prior to registration

Exclusion Criteria:

• Significant cognitive compromise

• History of CNS disease (e.g. brain metastases, seizure disorder, dementia)

• Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)

• Concurrent radiotherapy treatment

• Known hypersensitivity to olanzapine

• Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months

• History of diabetes mellitus on medication (insulin or oral glycemic agent)

• Alcohol abuse / chronic alcoholism

• History of closed angle glaucoma

• Current enrollment in other clinical trials