CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
fosaprepitant +3 moredrug
Likely dose
fosaprepitant 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01432015
NCT01432015Phase 4Completed

A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer

Gynecologic Oncology Associates·interventional·Posted Sep 12, 2011·Updated Mar 28, 2017

In Brief

A Phase 4 clinical trial evaluating fosaprepitant, aprepitant, and 2 other interventions for Ovarian Cancer and Uterine Cancer. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2011
Enrollment StartSep 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.8 years ago

Interventions

fosaprepitantdrug

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

aprepitantdrug

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

Oral Placeboother

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

IV placeboother

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