Overview

A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shiga University
Treatments:
Antiemetics
Aprepitant
Emetics
Fosaprepitant
Nedaplatin
Criteria
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