Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy

NCT02097823 | Completed Phase 2 Results DMC

• 1 other identifier: 1401283326
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of a larger trial comparing olanzapine and aprepitant and to obtain preliminary data on the effectiveness of these two medications to treat nausea and vomiting in children receiving chemotherapy. Children receiving 2 cycles of chemotherapy with a high risk of causing nausea and vomiting will receive olanzapine in one cycle and aprepitant in another cycle. Children will be randomized to see which medicine they receive first. The investigators will record the number of extra medications used for nausea, the number of times a child vomits, and the amount of nausea the child feels each day.

Conditions

Chemotherapy Induced Nausea and Vomiting

Keywords

olanzapine; Nausea and vomiting; aprepitant; pediatrics

Outcome Measures

Primary Outcomes (1)

• Feasibility of Recruitment and Data Collection.

  Primary objective of this study is to determine the feasibility of recruitment and data collection for conducting a larger trial. Recruitment and data collection will be feasible if at least 20 subjects can be recruited in 1 year and there is a 90% form completion rate.

  Approximately 1 year after study opens, at the conclusion of data collection. Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.

Secondary Outcomes (4)

• Complete Response in Overall Phase

  Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.

• Complete Response in Acute Phase

  Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.

• Complete Response in Delayed Phase

  Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.

• Good Control of Nausea

  Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.

Other Outcomes (1)

• Number of Participants With Adverse Events.

  Ongoing, throughout the study. Will be fully evaluated in approximately 1 year, at the conclusion of data collection. Each patient will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks.

Study Arms (2)

Aprepitant First, Olanzapine Second

EXPERIMENTAL

Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1. Olanzapine dosing: \>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses Aprepitant dosing: \>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses

Drug: Olanzapine; Drug: Aprepitant

Olanzapine First, Aprepitant Second

EXPERIMENTAL

Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1. Olanzapine dosing: \>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses \<20kg - 1.25mg orally daily for 4 doses Aprepitant dosing: \>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses \<20kg - 1.5-2mg/kg orally daily for 3 doses

Drug: Olanzapine; Drug: Aprepitant

Interventions

Olanzapine DRUG

Also known as: zyprexa

Aprepitant First, Olanzapine Second; Olanzapine First, Aprepitant Second

Aprepitant DRUG

Also known as: emend

Aprepitant First, Olanzapine Second; Olanzapine First, Aprepitant Second

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age greater than 4 years and less than 21 years
• patient will receive at least two cycles of the same regimen of highly emetogenic chemotherapy
• adequate liver function - defined as total bilirubin less than or equal to 1.5 times the upper limit of normal for age and AST/ALT less than or equal to upper limit of normal for age
• adequate kidney function - defined as creatinine clearance or GFR greater than or equal to 70mL/min/1.73m2 or a serum creatinine based on age/gender as follows: Maximum serum creatinine
• \<6 years: Male \& Female 0.8
• \<10 years: Male \& Female 1
• \<13 years: Male \& Female 1.2
• \<16 years: Male 1.5 Female 1.4
• \>16 years: Male 1.7 Female 1.4

You may not qualify if:

• known QTc prolongation or other cardiac arrhythmia
• current treatment with another antipsychotic (for example: risperidone, quetiapine, clozapine)
• prior adverse reaction to either olanzapine or aprepitant
• the planned two cycles of chemotherapy include ifosfamide (a patient may receive ifosfamide as a part of his/her overall treatment plan but not during study cycles)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Olanzapine; Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

This trial was a pilot study, limited by numbers of participants. Given the small numbers, during randomization (with 50/50 chance each subject randomized to group A or B) a disproportionate number of patients were randomized to group A.

Results Point of Contact

• Title: Dr. Catherine Long
• Organization: Prevea Health/St Vincent Hospital

cathy.long@prevea.com

9204338670

Study Officials

• Holly Knoderer, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 27, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Locations

US (1)