A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- The primary objective of this study is to explore efficacy of gemcitabine and epirubicin in the treatment of NSCLC patients who need palliative chemotherapy.
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- 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.