Clinical trial NCT00154739: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Combination, Chemotherapy,non-small cell lung cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology, National Taiwan University Hospital
name: Chin-Hsin Yang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D., Ph.D.
role: STUDY_CHAIR
References: