Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00154739
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.

Detailed Description

Most patients suffered from nausea, vomiting and prolonged anorexia after cisplatin treatment. Epirubicin is an anthracycline that was used widely in the treatment of cancer. Our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer patients showed a response rate of 52.6% and good median survival. However, most patients suffered from paclitaxel-related neurotoxicity.

Chemotherapy may increase an average of 1 to 2 months of median survival in inoperable non-small cell lung cancer patients treated with chemotherapy. However, chemotherapy may not provide a cure for these patients. Reduction of side effects and enhancement of life quality of the patients are as important as life prolongation for these patients. We designed a combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable non-small cell lung cancer. The treatment will be compared to gemcitabine and cisplatin combination.

Study Timeline

• Study Start: 1998-10
• Status Verified: 2005-07
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Last Update Submitted: 2008-08-01
• Last Update Posted: 2008-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
• No prior chemotherapy
• Age > 18 years
• ECOG score < 0 to 2
• Bi-dimensionally measurable lesions
• WBC > 4,000/ml, ANC > 1,500/ml, platelets>100,000/ml
• Hb>10g/dl.
• ALT/AST < 5 times x UNL, bilirubin < 1.5times x UNL, creatinine < 1.25 times x UNL, normal calcium level
• Life expectancy > 12 weeks

Exclusion Criteria

• CNS metastases, Concomitant myelosuppressive radiotherapy, C/T, hormonal therapy or immunotherapy.
• Active congestive heart failure, angina and/or arrhythmia requiring therapy or previous myocardial infarction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to explore efficacy of gemcitabine and epirubicin in the treatment of NSCLC patients who need palliative chemotherapy.

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to compare efficacy (response rate，overall survival) of gemcitabine/epirubicin to gemcitabine/cisplatin in the treatment of inoperable NSCLC.

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan