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

NCT02161991 | Completed Phase 3

• 1 other identifier: ACINV
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-small Cell Lung

Keywords

aprepitant; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• complete response rate of CINV

  complete response rate of CINV should be recorded when platinum based chemotherapy begun, during inhospital treatment, up to 6 months

  during treatment, up to 6 months

Secondary Outcomes (1)

• adverse event

  during treatment, up to 6 months

Study Arms (2)

aprepitant group

EXPERIMENTAL

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

Drug: Aprepitant

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Aprepitant DRUG

aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

Also known as: Emend

aprepitant group

placebo DRUG

placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Location

Related Publications (4)

• Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.

  PMID: 24276953 BACKGROUND

• Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11.

  PMID: 23062719 BACKGROUND

• Stiff PJ, Fox-Geiman MP, Kiley K, Rychlik K, Parthasarathy M, Fletcher-Gonzalez D, Porter N, Go A, Smith SE, Rodriguez TE. Prevention of nausea and vomiting associated with stem cell transplant: results of a prospective, randomized trial of aprepitant used with highly emetogenic preparative regimens. Biol Blood Marrow Transplant. 2013 Jan;19(1):49-55.e1. doi: 10.1016/j.bbmt.2012.07.019. Epub 2012 Aug 1.

  PMID: 22863840 BACKGROUND

• Albany C, Brames MJ, Fausel C, Johnson CS, Picus J, Einhorn LH. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012 Nov 10;30(32):3998-4003. doi: 10.1200/JCO.2011.39.5558. Epub 2012 Aug 20.

  PMID: 22915652 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nong Yang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of medical oncology, lung cancer and gastrointestinal cancer unit

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 12, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: January 31, 2018
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

CN (1)