Efficacy of Aprepitant (Emend®) in Children

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

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.

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:

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.