Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers
Conditions
Carcinoma, Non-small Cell Lung
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
aprepitant, non-small cell lung cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Aprepitant Type: Drug
Name: placebo Type: Drug
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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 are suitable for platinum based chemotherapy.

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
Location
Hunan province tumor hospital
Changsha, Hunan, China
Status: Recruiting
Contact: Chunhua Zhou, MD - +86 731 89762321 - zhouchunhua@hnszlyy.com
Start Date
June 2014
Completion Date
September 2015
Sponsors
Hunan Province Tumor Hospital
Source
Hunan Province Tumor Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page