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

Phase 3

Terminated

Conditions: Gynecologic Cancer

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

Registration Number: NCT04503668

Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 62

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nk1-RA	Compazine	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Nk1-RA	Ondansetron	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Nk1-RA	Dexamethasone	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Nk1-RA	Neurokinin-1 Receptor Antagonist (NK1-RA)	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Olanzapine	Ondansetron	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
Olanzapine	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
Olanzapine	Dexamethasone	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
Olanzapine	Compazine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.

Primary Outcome Measures

Name	Time	Method
Rate of complete response in the overall time period (0 - 120 hours post-chemotherapy)	At day 6	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.

Secondary Outcome Measures

Name	Time	Method
Rate of no nausea in the delayed time period (24 - 120 hours post-chemotherapy)	At day 6	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).
Rate of complete response in the acute time period (0 - 24 hours post-chemotherapy)	At day 2	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.
Rate of complete response in the delayed time period (24 - 120 hours post-chemotherapy)	At day 6	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.
Rate of no nausea in the acute time period (0 - 24 hours post-chemotherapy)	At day 2	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).
Rate of no nausea in the overall time period (0 - 120 hours post-chemotherapy)	At day 6	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).
Mean somnolence score	At day 6	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).
Mean increased-appetite score	At day 6	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).