Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT00625352
Recruitment Status : Unknown
Verified February 2008 by Ulsan University Hospital. Recruitment status was: Recruiting
Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.
Gemcitabine 1,250mg/m2 IV on D1 and D8 of every 3 weeks combined with UFT 400mg daily PO for 14 days every 3 weeks. Gemcitabine will be administered to patients a maximum of 4 cycles, and then discontinued. UFT will be continued until progression.
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Layout table for eligibility information
Ages Eligible for Study:
70 Years and older (Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
No prior chemotherapy
Existence of measurable disease. The measurable disease should not have been irradiated
Life expectancy of more than 3 months
Age ≥ 70 years
Performance status (ECOG):1 or 2
Adequate bone marrow function (Absolute neutrophil count >1500/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
Adequate liver (Bilirubin<2 times upper limit of normal and SGOT/SGPT<3 times upper limit of normal) and renal function (creatinine<1.5mg/dl)
Psychiatric illness or social situation that would preclude study compliance.
Other concurrent uncontrolled illness.
Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Currently/recently taken warfarin, phenprocoumon or phenytoin