Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers

Last updated: March 25, 2020
Sponsor: Hunan Province Tumor Hospital
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02161991
ACINV
  • Ages 18-75
  • All Genders

Study Summary

Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients pathologic diagnosed of advanced non-small cell lung cancer

  • according to NCCN non-small cell lung cancer guide line(2014 V2), patients aresuitable for platinum based chemotherapy.

Exclusion

Exclusion Criteria:

  • patients could not receive platinum based chemotherapy judged by clinical doctors

  • pregnancy or breast-feeding women

  • any serious disease which could not be controled

  • urine protein≥++, or 24h urine protein＞1g

  • less than 18 years old or more than 75 years old

Study Design

Total Participants: 244
Study Start date:
February 01, 2014
Estimated Completion Date:
January 31, 2018

Study Description

Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. 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. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.

Connect with a study center

  • Hunan Cancer hospital

    Changsha, Hunan
    China

    Site Not Available

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