Clinical trial NCT01661335: Efficacy of Aprepitant (Emend®) in Children
Official title: Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nausea
Vomiting
Childhood Cancer
Keywords: Nausea
Vomiting
Children
Aprepitant
Emend®
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.

Detailed description: 1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo.

1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.

Eligibility criteria: Inclusion Criteria:

under 20.99 years of age at enrollment

Scheduled to receive two identical cycles of highly emetogenic\[1\] chemotherapy for treatment of a primary malignancy, including:

Chemotherapy with any one or more of the following single agents in any combination:

* Carboplatin
* Carmustine \>250 mg/m2
* Cisplatin
* Cyclophosphamide ≥1 g/m2
* Dactinomycin
* High dose Methotrexate ≥ 5 g/m2

Or any of the following defined combinations:

* Cyclophosphamide + anthracycline
* Cyclophosphamide + etoposide
* Cytarabine 150-200 mg/m2 + daunorubicin
* Cytarabine 300 mg/m2 + etoposide
* Cytarabine 300 mg/m2 + teniposide
* Doxorubicin + ifosfamide
* Doxorubicin + methotrexate 5 g/m2
* Etoposide + ifosfamide

Exclusion Criteria:

* Patients who have received aprepitant in the past.
* Patients who demonstrate evidence of increased intracranial pressure.

Primary outcomes:
measure: Efficacy of aprepitant (Emend®) measured through a complete response
timeFrame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
measure: Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.
timeFrame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
measure: Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life
timeFrame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
measure: Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale
timeFrame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Secondary outcomes:
measure: Safety of aprepitant (Emend®)
timeFrame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Jimmy Everest Center for Cancer and Blood Disorders in Children
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Rene McNall-Knapp, MD
role: PRINCIPAL_INVESTIGATOR
References: