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

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ClinicalTrials.gov Identifier: NCT02161991
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small Cell Lung Drug: Aprepitant Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase 3 Study of Aprepitant Versus Placebo in Chinese Advanced Non-small Cell Lung Cancer Who Received Highly Emetogenic Chemotherapy
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

Arm Intervention/treatment
Experimental: aprepitant group
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
aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Other Name: Emend

Placebo Comparator: placebo
Patients assigned to placebo group should receive placebo for the control of CINV compared with aprepitant group.
Drug: placebo
placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.




Primary Outcome Measures :
  1. complete response rate of CINV [ 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


Secondary Outcome Measures :
  1. adverse event [ Time Frame: during treatment, up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161991


Locations
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China, Hunan
Hunan Cancer hospital
Changsha, Hunan, China
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
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Principal Investigator: Nong Yang, MD Hunan Cancer Hospital
Publications:

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Responsible Party: Yongchang Zhang, Director of department of medical oncology, lung cancer and gastrointestinal cancer unit, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT02161991    
Other Study ID Numbers: ACINV
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Keywords provided by Yongchang Zhang, Hunan Province Tumor Hospital:
aprepitant
non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action