A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclopho

• Status: Completed
• Trial end date: 2014-08-04
• Target enrollment: 0
• Participant gender: All

Summary

This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.

The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Alizapride; Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Dolasetron; Emetics; Fosaprepitant; Granisetron; Metoclopramide; Ondansetron; Tropisetron

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed malignant disease

• Scheduled to receive a single dose of one or more of moderately emetogenic chemotherapeutic agents during Cycle 1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or Karnofsky score ≥60

• Predicted life span ≥4 months

• Laboratory values demonstrating adequate hematologic status

• Premenopausal females must not be pregnant or lactating and must agree to use effective birth control

Exclusion Criteria:

• Received chemotherapy within 6 months prior to starting on study drugs

• Scheduled to receive subsequent treatment due to a refractory response to first or second line chemotherapy

• Received an investigational drug within 30 days prior to starting on study drugs

• Radiation therapy to the abdomen or pelvis in the week prior to starting on study drugs

• Vomiting in the 24 hours prior to starting on study drugs

• Active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy

• Known hypersensitivity to Aprepitant (EMEND®), Dexamethasone or 5-HT3 receptor antagonists

• Presentation with gastrointestinal obstruction symptoms

• Symptomatic primary or metastatic central nervous system malignancy