Status:
COMPLETED
Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2005
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00154739
Start Date
October 1 1998
End Date
July 1 2005
Last Update
August 4 2008
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 112