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Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors

NCT00572572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2016-04-06

Study results available
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Summary

Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.

Conditions

  • Germ Cell Tumors

Interventions

DRUG

Aprepitant

Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.

DRUG

Placebo

Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.

Sponsors & Collaborators

Principal Investigators

  • Lawrence Einhorn, M.D. · Hoosier Oncology Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00572572 on ClinicalTrials.gov