Hunan Cancer hospital
Changsha, Hunan, China
NCT Number: NCT02161991
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Changsha, Hunan, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Other names: Emend
placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Time frame: during treatment, up to 6 months
complete response rate of CINV should be recorded when platinum based chemotherapy begun, during inhospital treatment, up to 6 months
Time frame: during treatment, up to 6 months
Hunan Province Tumor Hospital
Other
Randomized Phase 3 Study of Aprepitant Versus Placebo in Chinese Advanced Non-small Cell Lung Cancer Who Received Highly Emetogenic Chemotherapy
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