NCT01037998

UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer

Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Iressa \[epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)\] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Combination of EGFR-TKI and anti-angiogenesis agents is a novel treatment.

Detailed description

Iressa is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is an orally active agent for advanced non-small-cell lung cancer (NSCLC) in those who have failed a previous platinum-based regimen and taxane treatment. UFUR (Tegafur/Uracil) is effective agent against chemo-naïve NSCLC. It has anti-angiogenesis effect when used as long-term low dose treatment. Present phase II randomized clinical trial is designed to answer whether or not adding an oral anti-angiogenesis agent (UFUR), that has low toxicity profiles when long term use, to EGFR-TKI (Iressa) could increase patients survival and response rate.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	UFUR and Iressa	Iressa 250 mg daily plus UFUR 1# bid

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-12-23
• Last updated: 2009-12-23

Locations

1 site across 1 country: Taiwan