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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: UFUR and Iressa


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Iressa 250 mg daily treatment plus UFUR twice daily treatment | Drug: UFUR and Iressa<br>* Iressa 250 mg daily plus UFUR 1# bid<br>* Other names: UFUR;|
| No Intervention: B<br>Gefitinib 250 mg daily treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compared the 6-month survival rate of these two arms of treatment. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma, non-small-cell lung cancer, gefitinib, UFUR