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

Primary Purpose

Gynecologic Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Dexamethasone
Neurokinin-1 Receptor Antagonist (NK1-RA)
Olanzapine
Compazine
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Rogel Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nk1-RA

Olanzapine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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).
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).
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).

Full Information

First Posted
August 3, 2020
Last Updated
September 11, 2023
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04503668
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nk1-RA
Arm Type
Active Comparator
Arm Description
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
20 mg IV on day 1 pre-chemotherapy
Intervention Type
Drug
Intervention Name(s)
Neurokinin-1 Receptor Antagonist (NK1-RA)
Other Intervention Name(s)
Fosaprepitant
Intervention Description
150 mg IV on day 1 pre-chemotherapy
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
5 mg by mouth on days 1-4 of chemotherapy (taken at night)
Intervention Type
Drug
Intervention Name(s)
Compazine
Intervention Description
5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Primary Outcome Measure Information:
Title
Rate of complete response in the overall time period (0 - 120 hours post-chemotherapy)
Description
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.
Time Frame
At day 6
Secondary Outcome Measure Information:
Title
Rate of complete response in the acute time period (0 - 24 hours post-chemotherapy)
Description
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.
Time Frame
At day 2
Title
Rate of complete response in the delayed time period (24 - 120 hours post-chemotherapy)
Description
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.
Time Frame
At day 6
Title
Rate of no nausea in the acute time period (0 - 24 hours post-chemotherapy)
Description
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).
Time Frame
At day 2
Title
Rate of no nausea in the delayed time period (24 - 120 hours post-chemotherapy)
Description
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).
Time Frame
At day 6
Title
Rate of no nausea in the overall time period (0 - 120 hours post-chemotherapy)
Description
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).
Time Frame
At day 6
Title
Mean somnolence score
Description
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).
Time Frame
At day 6
Title
Mean increased-appetite score
Description
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).
Time Frame
At day 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shitanshu Uppal, MBBS
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin McCarthy
Phone
734-615-5118
Email
caitlimc@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Aimee Rolston, MD, MS
Email
aimeerol@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Shitanshu Uppal, MBBS
First Name & Middle Initial & Last Name & Degree
Aimee Rolston, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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