Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment aprepitant
Sponsor Shiga University
Start date April 2012
End date March 2015
Trial size 10 participants
Trial identifier NCT02364804, 24-20

Summary

The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control

Primary Outcomes

Measure
Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting
time frame: Fifteen days after beginning of each cycle of chemotherapy

Secondary Outcomes

Measure
Influence on clinical outcome: Survival
time frame: Participants will be followed for 3 years after the last treatment

Eligibility Criteria

Male or female participants from 20 years up to 79 years old.

Inclusion Criteria: 1. Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer. 2. ECOG performance status 0-1. 3. Aged 20-79 years old. 4. Laboratory values as follows 4000/mm3 < WBC < 12000/mm3, neutrophil count > 2000/mm3, platelet count > 100000/mm3, hemoglobin > 9.5g/dL, asparate transaminase < 2.5 X cutoff value, alanine transaminase < 2.5 X cutoff value, total bilirubin < 1.5g/dL, Serum creatinine < cutoff value, PaO2 > 60 Torr. 5. Able and willing to give valid written informed consent. Exclusion Criteria: 1. Allergy against polysorbert 80 or platinum-containing drugs. 2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency). 3. Active and uncontrolled infectious disease. 4. Massive pleural or pericardial effusion. 5. Other malignancy requiring treatment. 6. Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential) 7. Peripheral nerve disorder. 8. Pregnant or lactating women. 9. Concurrent administration of pimozide. 10. Decision of unsuitableness by principal investigator or physician-in-charge

Additional Information

Official title A Study to Evaluate the Efficacy of Anti-emetic Drug Aprepitant Upon the Combination Chemotherapy of Nedaplatin and Docetaxel for Non-small Cell Lung Cancer
Principal investigator Yataro Daigo, MD, PhD
Description The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Shiga University.