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

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

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

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

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

- Active congestive heart failure, angina and/or arrhythmia requiring therapy or
previous myocardial infarction

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective of this study is to explore efficacy of gemcitabine and epirubicin in the treatment of NSCLC patients who need palliative chemotherapy.

Principal Investigator

Chin-Hsin Yang, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

October 1998

Completion Date:

July 2005

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Combination, Chemotherapy,non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms