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

Last updated: June 4, 2025
Sponsor: University of Michigan Rogel Cancer Center
Overall Status: Terminated

Phase

3

Condition

Vaginal Cancer

Pelvic Cancer

Vomiting

Treatment

Ondansetron

Neurokinin-1 Receptor Antagonist (NK1-RA)

Olanzapine

Clinical Study ID

NCT04503668
UMCC 2019.173
HUM00175458
  • Ages 18-89
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 toregistration

Exclusion

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 myocardialinfarction 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

Study Design

Total Participants: 62
Treatment Group(s): 5
Primary Treatment: Ondansetron
Phase: 3
Study Start date:
December 28, 2020
Estimated Completion Date:
March 11, 2024

Connect with a study center

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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