Efficacy of Aprepitant (Emend®) in Children

University of Oklahoma (OU)

Status and phase: Completed; Phase 3

Conditions: Vomiting; Nausea; Childhood Cancer

Treatments: Drug: Ondansetron, Dexamethasone, placebo; Drug: Ondansetron, dexamethasone, aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT01661335

0413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 6 months to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

Ondansetron, dexamethasone, aprepitant

Experimental group

Description:

Arm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.

Treatment:

Drug: Ondansetron, dexamethasone, aprepitant

Ondansetron, Dexamethasone, placebo

Placebo Comparator group

Description:

Arm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.

Treatment:

Drug: Ondansetron, Dexamethasone, placebo