Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT00625352
• Lead Sponsor: Ulsan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-02
• Study Start: 2008-02
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Last Update Submitted: 2008-02-19
• Study First Posted: 2008-02-28
• Last Update Posted: 2008-02-28
• Primary Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
overall response rate	every two cycles

Secondary Outcome Measures

Name	Time	Method
toxicity, response duration, progression free survival, overall survival	according to protocol

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of