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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Gefitinib

Criteria

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.