Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, Aged, Gemcitabine, UFT
Brief summary
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.
Interventions
DRUGGemcitabine, UFT
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.
Sponsors
Jeil Pharmaceutical Co., Ltd.
Ulsan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Informed consent
Exclusion criteria
* 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 * Hypersensitivity history to any drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | every two cycles |
Secondary
| Measure | Time frame |
|---|---|
| toxicity, response duration, progression free survival, overall survival | according to protocol |
Countries
South Korea
Contacts
Primary ContactYoung Joo Min, M.D.
Outcome results
None listed