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Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy


Phase 3
N/A
20 Years
Not Enrolling
Both
Nausea, Vomiting, Childhood Cancer

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Trial Information

Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy


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.


Inclusion Criteria:



- 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

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Efficacy of aprepitant (Emend®) measured through a complete response

Outcome Description:

• Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles.

Outcome Time Frame:

Up to 11 weeks, or until 3 weeks after the second course of the study regimen

Safety Issue:

No

Principal Investigator

Rene McNall-Knapp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Food and Drug Administration

Study ID:

0413

NCT ID:

NCT01661335

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Nausea
  • Vomiting
  • Childhood Cancer
  • Nausea
  • Vomiting
  • Children
  • Aprepitant
  • Emend®
  • Nausea
  • Vomiting

Name

Location
Jimmy Everest Center for Cancer and Blood Disorders in Children Oklahoma City, Oklahoma  73104