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 rateļ¼overall 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
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