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

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.

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