Gynecologic CancerPhase 3NCT04503668

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

A Phase 3 study testing Ondansetron, Dexamethasone and Neurokinin-1 Receptor Antagonist (NK1-RA) in people with Gynecologic Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 to 89 years, women only
Conditions the study is for: Gynecologic Cancer
What is being tested?: Ondansetron, Dexamethasone and Neurokinin-1 Receptor Antagonist (NK1-RA)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 28 Dec 2020to 11 Mar 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 10Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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

Conditions: Gynecologic Cancer
Being tested: Ondansetron, Dexamethasone, Neurokinin-1 Receptor Antagonist (NK1-RA), Olanzapine, Compazine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OndansetronDrug
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
DexamethasoneDrug
20 mg IV on day 1 pre-chemotherapy
Neurokinin-1 Receptor Antagonist (NK1-RA)Drug
Also called Fosaprepitant
150 mg IV on day 1 pre-chemotherapy
OlanzapineDrug
Also called Zyprexa
5 mg by mouth on days 1-4 of chemotherapy (taken at night)
CompazineDrug
5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Study groups in NCT04503668
Study group	Role	What they receive
Nk1-RA	Active comparator	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Receives: 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. Receives: Drug: Ondansetron; Drug: Dexamethasone; Drug: Olanzapine; Drug: Compazine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: 24 hours post initiating chemotherapy during cycle 1
Rate of Complete Response in the Delayed Time Period (24 - 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.
Measured: 24-120 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
Measured: 24 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
Measured: 120 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).
Measured: 120 hours post initiating chemotherapy during cycle 1
Mean Somnolence Score
Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).
Measured: assessed daily, and reported at day 6 post final study treatment
Mean Increased-appetite Score
Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).
Measured: assessed daily, and reported at day 6 post final study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 202011 Mar 2024

First posted7 Aug 2020
Study start28 Dec 2020
Primary completion3 Jan 2024
Study completion11 Mar 2024

Why it stopped: Lack of Patient Population

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gynecologic CancerStudies of the same condition, open and under way.
More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04503668
Sponsor's protocol ID: UMCC 2019.173
Other IDs: HUM00175458
Status last verified: Jun 2025
First submitted: 3 Aug 2020
Last updated: 18 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gynecologic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04503668
Acronym / sponsor ID: UMCC 2019.173
Conditions: Gynecologic Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of Patient Population
Enrolment: 62 participants (actual)
Lead sponsor: University of Michigan Rogel Cancer CenterUniversity, hospital or other
Study start: 28 Dec 2020 (actual)
Primary completion: 3 Jan 2024 (actual)
Study completion: 11 Mar 2024 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 18 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nk1-RA	Active comparator	Drug: Ondansetron, Drug: Dexamethasone, Drug: Neurokinin-1 Receptor Antagonist (NK1-RA), Drug: CompazineNk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Olanzapine	Experimental	Drug: Ondansetron, Drug: Dexamethasone, Drug: Olanzapine, Drug: CompazineOlanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.

Who may qualify

Ages: 18 to 89 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ondansetron8 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	Drug	Nk1-RA, Olanzapine
Dexamethasone20 mg IV on day 1 pre-chemotherapy	Drug	Nk1-RA, Olanzapine
Neurokinin-1 Receptor Antagonist (NK1-RA)Also: Fosaprepitant150 mg IV on day 1 pre-chemotherapy	Drug	Nk1-RA
OlanzapineAlso: Zyprexa5 mg by mouth on days 1-4 of chemotherapy (taken at night)	Drug	Olanzapine
Compazine5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Drug	Nk1-RA, Olanzapine

Primary outcome

Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
Time frame: 120 hours post initiating chemotherapy during cycle 1
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.

7 secondary outcomes

Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
Time frame: 24 hours post initiating chemotherapy during cycle 1
Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
Time frame: 24-120 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
Time frame: 24 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
Time frame: 120 hours post initiating chemotherapy during cycle 1
Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
Time frame: 120 hours post initiating chemotherapy during cycle 1
Mean Somnolence Score
Time frame: assessed daily, and reported at day 6 post final study treatment
Mean Increased-appetite Score
Time frame: assessed daily, and reported at day 6 post final study treatment

Results and safety

Results posted to the registry on 18 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nk1-RA	31	24
Olanzapine	31	27

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

Time frame: 120 hours post initiating chemotherapy during cycle 1. Count of participants. Unit: Participants

Measure	Nk1-RA n = 27	Olanzapine n = 24
Value	11	14

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nk1-RA	3 of 27 (11.1%)	24 of 27 (88.9%)	4 of 27
Olanzapine	5 of 24 (20.8%)	23 of 24 (95.8%)	6 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aimee Rolston principal investigator

University of Michigan Rogel Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy) (time frame: 120 hours post initiating chemotherapy during cycle 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04503668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.