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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: UFUR and Iressa

• Registration Number: NCT01037998
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2008-05-27
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted QC: 2009-12-22
• Last Update Submitted: 2009-12-22
• Study First Posted: 2009-12-23
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Histologic or cytological diagnosis of NSCLC who failed previous platinum-based and taxanes chemotherapy.
• No prior radiotherapy on measurable lesion(s).
• Performance status of 0 to 3 on the Zubrod scale. (Reference 1)
• Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by CT scan, MRI, or chest x-ray.
• Informed consent from patient.
• Males or females 18 years of age or older.
• If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial.

Exclusion Criteria

• Active infection (at the discretion of the investigator).
• Inadequate liver function (total bilirubin >1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 5 times normal.
• Inadequate renal function (creatinine >2.0 mg/dL).
• Breast feeding.
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
• Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	UFUR and Iressa	Iressa 250 mg daily treatment plus UFUR twice daily treatment

Primary Outcome Measures

Name	Time	Method
To assess and compared the 6-month survival rate of these two arms of treatment.	6 months

Secondary Outcome Measures

Name	Time	Method
To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.	6 months

Trial Locations

Locations (1)

Taipei VGH; 🇨🇳 Taipei City, Taiwan