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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Cisplatin; Epirubicin; Gemcitabine

Criteria

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