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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364804
• Other study ID #: 24-20
• Status: Completed
• Start date: April 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2020
• Source: Shiga University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Aprepitant
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 but Aprepitant.

Locations

Country	Name	City	State
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga

Sponsors (1)

Lead Sponsor	Collaborator
Shiga University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting		Fifteen days after beginning of each cycle of chemotherapy
Secondary	Influence on clinical outcome: Survival		Participants will be followed for 3 years after the last treatment