Status:
UNKNOWN
Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
Lead Sponsor:
Ulsan University Hospital
Collaborating Sponsors:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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. Gemcit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00625352
Start Date
February 1 2008
Last Update
February 28 2008
Active Locations (1)
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1
Ulsan University Hospital
Ulsan, South Korea, 682-714