Nausea | 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)
Nausea research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AprepitantAprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3
Drug:Aprepitant PlaceboAprepitant Placebo (PO, QD) on Days 1, 2, and 3
Drug:OndansetronOndansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3
Drug:DexamethasoneDexamethasone (20 mg or 12 mg, PO) on Day 1
Drug:Ondansetron PlaceboOndansetron Placebo (PO, BID) on Days 2 and 3
Drug:Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).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).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Aprepitant RegimenParticipants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
Control RegimenParticipants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
Start Date: December 12, 2012
Completed Date: August 4, 2014
Phase: Phase 4
Primary Outcome: The Percentage of Participants With No Vomiting - Overall Stage
Secondary Outcome: Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
Study sponsors, principal investigator, and references
Principal Investigator: Medical Director
Kim JE, Jang JS, Kim JW, Sung YL, Cho CH, Lee MA, Kim DJ, Ahn MJ, Lee KY, Sym SJ, Lim MC, Jung H, Cho EK, Min KW. Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Support Care Cancer. 2017 Mar;25(3):801-809. doi: 10.1007/s00520-016-3463-0. Epub 2016 Nov 8. Erratum in: Support Care Cancer. 2017 Feb 14;:. Support Care Cancer. 2017 May;25(5):1741.