Efficacy of Aprepitant (Emend®) in Children

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661335
• Other study ID #: 0413
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2012
• Est. completion date: June 29, 2017

Study information

• Verified date: March 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer
• Nausea
• Vomiting

Intervention

Drug:
• Ondansetron, dexamethasone, aprepitant
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.
• Ondansetron, Dexamethasone, placebo
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%.

Locations

Country	Name	City	State
United States	Jimmy Everest Center for Cancer and Blood Disorders in Children	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of aprepitant (Emend®) measured through a complete response	• 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.	Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Primary	Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.	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.	Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Primary	Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life	• A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire	Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Primary	Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale	• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.	Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Secondary	Safety of aprepitant (Emend®)	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.	Up to 11 weeks, or until 3 weeks after the second course of the study regimen