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

Hunan Province Tumor Hospital

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-small Cell Lung

Treatments: Drug: Aprepitant; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02161991

ACINV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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244 participants in 2 patient groups, including a placebo group

aprepitant group

Experimental group

Description:

Patients assigned to aprepitant group should receive aprepitant for the control of CINV, aprepitant 125 mg for day1, 80mg for day2 and day3.

Treatment:

Drug: Aprepitant

placebo

Placebo Comparator group

Description:

Patients assigned to placebo group should receive placebo for the control of CINV compared with aprepitant group.

Treatment:

Drug: placebo