Back to resultsGemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
Epirubicin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Combination, Chemotherapy,non-small cell lung cancer
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
Sites / Locations
- Department of Oncology, National Taiwan University Hospital
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00154739
First Posted
September 8, 2005
Last Updated
August 1, 2008
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00154739
Brief Title
Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Combination, Chemotherapy,non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Hsin Yang, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)
We'll reach out to this number within 24 hrs