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Olanzapine for Chemotherapy-Induced Nausea and Vomiting in Gynecologic Cancer

Phase 3
Waitlist Available
Led By Shitanshu Uppal, MBBS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of gynecologic malignancy
ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 6
Awards & highlights

Study Summary

This trial will compare the effectiveness of olanzapine versus neurokinin-1 receptor antagonists in preventing chemotherapy-induced nausea and vomiting in gynecologic cancer patients receiving outpatient chemotherapy.

Who is the study for?
This trial is for patients with gynecologic cancers who haven't had chemotherapy in the last year, are about to receive specific chemo drugs every three weeks, can perform daily activities (ECOG 0 or 1), speak English, and can consent. Excluded are those with brain conditions, recent antipsychotic use (except antidepressants), ongoing radiotherapy, olanzapine allergy, certain heart issues, diabetes on medication, alcohol abuse, glaucoma or participation in other trials.Check my eligibility
What is being tested?
The study is testing if olanzapine is better than NK1-RA drugs at preventing nausea and vomiting caused by a one-day outpatient chemo regimen of carboplatin and paclitaxel given every three weeks to women with gynecological cancers.See study design
What are the potential side effects?
Olanzapine may cause drowsiness, increased appetite leading to weight gain; dry mouth; restlessness; constipation; and potentially more serious side effects like changes in blood sugar levels. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a cancer that affects my reproductive organs.
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I am fully active or can carry out light work.
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I am scheduled for Carboplatin and Paclitaxel treatment every 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of complete response in the overall time period (0 - 120 hours post-chemotherapy)
Secondary outcome measures
Mean increased-appetite score
Mean somnolence score
Rate of complete response in the acute time period (0 - 24 hours post-chemotherapy)
+4 more

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656
31%
Increased appetite
31%
Hypersalivation
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Difficulty concentrating
8%
Abnormal white blood count
8%
Insomnia
8%
Enuresis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olanzapine Group
Clozapine Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OlanzapineExperimental Treatment4 Interventions
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
Group II: Nk1-RAActive Control4 Interventions
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Compazine
2017
Completed Phase 4
~90
Olanzapine
2005
Completed Phase 4
~5480
Ondansetron
2011
Completed Phase 4
~4010
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,209 Total Patients Enrolled
2 Trials studying Gynecologic Cancers
120 Patients Enrolled for Gynecologic Cancers
Shitanshu Uppal, MBBSPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
1 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
102 Patients Enrolled for Gynecologic Cancers
Aimee RolstonPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
~14 spots leftby May 2025
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