Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Inclusion Criteria:

• Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater
• Patient is post menopausal or, if premenopausal, must use double-barrier contraception

Exclusion Criteria:

• Patient has symptomatic primary or metastatic CNS malignancy
• Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6
• Patient has vomited in the 24 hours prior to treatment Day 1
• Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse
• Patient is pregnant or breast feeding