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Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
Conditions
Carcinoma, Non-Small-Cell Lung
Conditions: official terms
Carcinoma - Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Carcinoma, Non-Small-Cell Lung, Aged, Gemcitabine, UFT
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine, UFT
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
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
- 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
Location
Ulsan University Hospital
Ulsan, Korea, Republic of
Status: Recruiting
Contact: Jin Sun Yoon - 82-52-250-7010
Start Date
February 2008
Sponsors
Ulsan University Hospital
Source
Ulsan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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