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Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting

NCT01432015 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-28

Study results available
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Summary

Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.

Conditions

Interventions

DRUG

fosaprepitant

Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications

DRUG

aprepitant

Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications

OTHER

Oral Placebo

One pill administered on days 1-3 in conjunction with Fosaprepitant.

OTHER

IV placebo

100 cc of IV placebo administered on day in conjunction with Aprepitant

Sponsors & Collaborators

Principal Investigators

  • John P Micha, MD · Gynecologic Oncology Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432015 on ClinicalTrials.gov