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 Cyclophosphamide Regimens) (MK-0869-225) (KMEC)
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Aprepitant; Aprepitant Placebo; Ondansetron; Dexamethasone; Ondansetron Placebo; Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
Intervention description: Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3; Aprepitant Placebo (PO, QD) on Days 1, 2, and 3; Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3; Dexamethasone (20 mg or 12 mg, PO) on Day 1; Ondansetron Placebo (PO, BID) on Days 2 and 3; Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; Metoclopramide; Granisetron; Tropisetron; Dolasetron; Alizapride; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 494.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: chemotherapy; nausea; vomiting; emetogenic; cancer; antiemetics; tumor

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.
    

Eligibility 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