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Trial Title:
Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
NCT ID:
NCT00625352
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Gemcitabine
Conditions: Keywords:
Carcinoma, Non-Small-Cell Lung
Aged
Gemcitabine
UFT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine, UFT
Description:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ulsan University Hospital
Address:
City:
Ulsan
Zip:
682-714
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin Sun Yoon
Phone:
82-52-250-7010
Start date:
February 2008
Lead sponsor:
Agency:
Ulsan University Hospital
Agency class:
Other
Collaborator:
Agency:
Jeil Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Ulsan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00625352
