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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Aprepitant; Fosaprepitant; Olanzapine

Criteria

Inclusion Criteria:

• 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

• 2- <6 years: Male & Female 0.8

• 6- <10 years: Male & Female 1

• 10- <13 years: Male & Female 1.2

• 13- <16 years: Male 1.5 Female 1.4

• >16 years: Male 1.7 Female 1.4

Exclusion Criteria:

• 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)