Back to resultsEfficacy of Aprepitant (Emend®) in Children
Primary Purpose
Nausea, Vomiting, Childhood Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ondansetron, dexamethasone, aprepitant
Ondansetron, Dexamethasone, placebo
Sponsored by
About this trial
This is an interventional prevention trial for Nausea focused on measuring Nausea, Vomiting, Children, Aprepitant, Emend®
Eligibility Criteria
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.
Sites / Locations
- Jimmy Everest Center for Cancer and Blood Disorders in Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ondansetron, dexamethasone, aprepitant
Ondansetron, Dexamethasone, placebo
Arm 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.
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%.
Outcomes
Primary Outcome Measures
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.
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.
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
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale
• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01661335
Brief Title
Efficacy of Aprepitant (Emend®) in Children
Official Title
Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Childhood Cancer
Keywords
Nausea, Vomiting, Children, Aprepitant, Emend®
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron, dexamethasone, aprepitant
Arm Type
Experimental
Arm 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.
Arm Title
Ondansetron, Dexamethasone, placebo
Arm Type
Placebo Comparator
Arm 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%.
Intervention Type
Drug
Intervention Name(s)
Ondansetron, dexamethasone, aprepitant
Other Intervention Name(s)
Aprepitant = Emend, ARM A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ondansetron, Dexamethasone, placebo
Other Intervention Name(s)
ARM B
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Efficacy of aprepitant (Emend®) measured through a complete response
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.
Time Frame
Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Title
Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.
Description
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.
Time Frame
Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Title
Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life
Description
• A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire
Time Frame
Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Title
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale
Description
• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.
Time Frame
Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Secondary Outcome Measure Information:
Title
Safety of aprepitant (Emend®)
Description
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.
Time Frame
Up to 11 weeks, or until 3 weeks after the second course of the study regimen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene McNall-Knapp, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jimmy Everest Center for Cancer and Blood Disorders in Children
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Aprepitant (Emend®) in Children
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