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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154739
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 4, 2008
Information provided by:
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Gemcitabine Drug: Cisplatin Drug: Epirubicin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer
Study Start Date : October 1998
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154739

Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chin-Hsin Yang, M.D., Ph.D. Department of Oncology, National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, M.D., Ph.D. Department of Oncology, National Taiwan University Hospital Identifier: NCT00154739     History of Changes
Other Study ID Numbers: 46S1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: July 2005

Keywords provided by National Taiwan University Hospital:
Combination, Chemotherapy,non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors