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

NCT04503668 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: UMCC 2019.173HUM00175458
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)

  Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

  120 hours post initiating chemotherapy during cycle 1

Secondary Outcomes (7)

• Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)

  24 hours post initiating chemotherapy during cycle 1

• Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)

  24-120 hours post initiating chemotherapy during cycle 1

• Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)

  24 hours post initiating chemotherapy during cycle 1

• Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)

  120 hours post initiating chemotherapy during cycle 1

• Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)

  120 hours post initiating chemotherapy during cycle 1

Study Arms (2)

Nk1-RA

ACTIVE COMPARATOR

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

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

Olanzapine

EXPERIMENTAL

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

Drug: Ondansetron; Drug: Dexamethasone; Drug: Olanzapine; Drug: Compazine

Interventions

Ondansetron DRUG

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

Nk1-RA; Olanzapine

Dexamethasone DRUG

20 mg IV on day 1 pre-chemotherapy

Nk1-RA; Olanzapine

Neurokinin-1 Receptor Antagonist (NK1-RA) DRUG

150 mg IV on day 1 pre-chemotherapy

Also known as: Fosaprepitant

Nk1-RA

Olanzapine DRUG

5 mg by mouth on days 1-4 of chemotherapy (taken at night)

Also known as: Zyprexa

Olanzapine

Compazine DRUG

5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Nk1-RA; Olanzapine

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Ondansetron; Dexamethasone; Neurokinin-1 Receptor Antagonists; fosaprepitant; Olanzapine; Prochlorperazine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Benzodiazepines; Benzazepines; Phenothiazines; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Aimee Rolston

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: December 28, 2020
• Primary Completion: January 3, 2024
• Study Completion: March 11, 2024
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)