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

University of Michigan Rogel Cancer Center

Status and phase: Terminated; Phase 3

Conditions: Gynecologic Cancer

Treatments: Drug: Dexamethasone; Drug: Olanzapine; Drug: Compazine; Drug: Ondansetron; Drug: Neurokinin-1 Receptor Antagonist (NK1-RA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04503668

UMCC 2019.173

HUM00175458 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Nk1-RA

Active Comparator group

Description:

Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.

Treatment:

Drug: Neurokinin-1 Receptor Antagonist (NK1-RA)

Drug: Ondansetron

Drug: Compazine

Drug: Dexamethasone

Olanzapine

Experimental group

Description:

Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.

Treatment:

Drug: Ondansetron

Drug: Compazine

Drug: Olanzapine

Drug: Dexamethasone