Efficacy of Aprepitant (Emend®) in Children
- Conditions
- VomitingNauseaChildhood Cancer
- Interventions
- Drug: Ondansetron, Dexamethasone, placebo
- Registration Number
- NCT01661335
- Lead Sponsor
- University of Oklahoma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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
- Patients who have received aprepitant in the past.
- Patients who demonstrate evidence of increased intracranial pressure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ondansetron, Dexamethasone, placebo Ondansetron, Dexamethasone, placebo 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%. Ondansetron, dexamethasone, aprepitant Ondansetron, dexamethasone, aprepitant 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.
- Primary Outcome Measures
Name Time Method Efficacy of aprepitant (Emend®) measured through a complete response Up to 11 weeks, or until 3 weeks after the second course of the study regimen • 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.
Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication. Up to 11 weeks, or until 3 weeks after the second course of the study regimen * The total episodes of emesis within 7 days of the first chemotherapy administration of each cycle.
* The total number of administrations of rescue medications given for breakthrough nausea or vomiting.Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life Up to 11 weeks, or until 3 weeks after the second course of the study regimen • A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale Up to 11 weeks, or until 3 weeks after the second course of the study regimen • A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.
- Secondary Outcome Measures
Name Time Method Safety of aprepitant (Emend®) Up to 11 weeks, or until 3 weeks after the second course of the study regimen * Occurrence of adverse events as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. These will be reported spontaneously or on inquiry by the investigator/study nurse, and continuously monitored throughout the trial.
* Weekly complete blood count (CBC) for 3 weeks after each investigational antiemetic cycle.
* Weekly complete metabolic profile (CMP) for 3 weeks after each investigational antiemetic cycle.
Trial Locations
- Locations (1)
Jimmy Everest Center for Cancer and Blood Disorders in Children
🇺🇸Oklahoma City, Oklahoma, United States