NCT00625352

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ulsan University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Gemcitabine, UFT	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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-12-01
• First posted: 2008-02-28
• Last updated: 2008-02-28

Locations

1 site across 1 country: South Korea