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

Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Gemcitabine (Drug); Cisplatin (Drug); Epirubicin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Chin-Hsin Yang, M.D., Ph.D., Principal Investigator, Affiliation: Department of Oncology, National Taiwan University Hospital
Ann-Lii Cheng, M.D., Ph.D., Study Chair, Affiliation: Department of Oncology, National Taiwan University Hospital

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.

Clinical Details

Official title: A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: The secondary objective of this study is to compare efficacy (response rateļ¼Œoverall survival) of gemcitabine/epirubicin to gemcitabine/cisplatin in the treatment of inoperable NSCLC.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Department of Oncology, National Taiwan University Hospital, Taipei 112, Taiwan
Additional Information

Starting date: October 1998
Last updated: August 1, 2008

Page last updated: August 23, 2015

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