Non-Small-Cell Lung Cancer
Conditions
Keywords
adenocarcinoma, non-small-cell lung cancer, gefitinib, UFUR
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.
Interventions
DRUGUFUR and Iressa
Iressa 250 mg daily plus UFUR 1# bid
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compared the 6-month survival rate of these two arms of treatment. | 6 months |
Secondary
| Measure | 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 |
Countries
Taiwan
Outcome results
None listed