Clinical trial NCT04503668: Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gynecologic Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
timeFrame: 120 hours post initiating chemotherapy during cycle 1
Secondary outcomes:
measure: Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
timeFrame: 24 hours post initiating chemotherapy during cycle 1
measure: Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
timeFrame: 24-120 hours post initiating chemotherapy during cycle 1
measure: Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)
timeFrame: 24 hours post initiating chemotherapy during cycle 1
measure: Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)
timeFrame: 120 hours post initiating chemotherapy during cycle 1
measure: Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
timeFrame: 120 hours post initiating chemotherapy during cycle 1
measure: Mean Somnolence Score
timeFrame: assessed daily, and reported at day 6 post final study treatment
measure: Mean Increased-appetite Score
timeFrame: assessed daily, and reported at day 6 post final study treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Aimee Rolston
role: PRINCIPAL_INVESTIGATOR
References: