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Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

NCT02445872•Zhejiang University

View on ClinicalTrials.gov

Summary

Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.

Detailed Description

Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2015 V1).The patient should receive a 3-day cisplatin-based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant(125 mg po at day1, 80 mg at day2-3) combination with palonosetron and dexamethasone(5mg iv at day1-3, 3.75mg po at day4-5). In placebo group patients would receive palonosetron and dexamethasone(5mg iv at day1-3, 7.5mg po at day4-5).During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient who was confirmed lung cancer by pathologic histology or cytology.
•2. Males or females aged ≥18 years, \<80 years.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
•4. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
•5. Patients with asymptomatic, treated brain metastases are eligible for trial participation.
•6. Adequate bone marrow, renal, and liver function are required.
•7. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
•8. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria

•1. History of sensitivity/idiosyncrasy to aprepitant or excipients
•2. Condition that might interfere with drug absorption, distribution metabolism or excretion.
•3. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
•4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
•5. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
•6. Female subjects should not be pregnant or breast-feeding.
•7. Inadequate hematological function.
•8. Abnormal liver and renal function.
•9. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Locations (1)

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 1, 2015

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

December 9, 2015

Enrollment

ESTIMATED participants

Conditions

Chemotherapy-Induced Nausea and VomitingLung Cancer

Interventions

Aprepitant

DRUG

Palonosetron

DRUG

Dexamethasone

DRUG

Contacts

Qiong Zhao, MD

CONTACT

0571-87236802 doczq.2008@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

Inclusion Criteria

Exclusion Criteria

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