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Completed

NCT Number: NCT01661335

Efficacy of Aprepitant (Emend®) in Children

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.

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Key information

Conditions

Nausea Childhood Cancer Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

6 month–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jimmy Everest Center for Cancer and Blood Disorders in Children

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ondansetron, dexamethasone, aprepitant

Drug

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.

Other names: Aprepitant = Emend, ARM A

Ondansetron, Dexamethasone, placebo

Drug

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%.

Other names: ARM B

Primary outcomes

  1. Efficacy of aprepitant (Emend®) measured through a complete response

    Time frame: 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.

  2. Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.

    Time frame: 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.

  3. Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life

    Time frame: 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

  4. Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale

    Time frame: 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 outcomes

  1. Safety of aprepitant (Emend®)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2012
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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