UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa|
- To assess and compared the 6-month survival rate of these two arms of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A
Iressa 250 mg daily treatment plus UFUR twice daily treatment
Drug: UFUR and Iressa
Iressa 250 mg daily plus UFUR 1# bid
Other Name: UFUR
No Intervention: B
Gefitinib 250 mg daily treatment
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.