Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFebruary 28, 2008
February 1, 2008
1.8 years
February 19, 2008
February 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
every two cycles
Secondary Outcomes (1)
toxicity, response duration, progression free survival, overall survival
according to protocol
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulsan University Hospitallead
- Jeil Pharmaceutical Co., Ltd.collaborator
Study Sites (1)
Ulsan University Hospital
Ulsan, 682-714, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2008
First Posted
February 28, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2009
Last Updated
February 28, 2008
Record last verified: 2008-02