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

Taipei Veterans General Hospital

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell Lung Cancer

Treatments

Drug: UFUR and Iressa

Study type

Interventional

Funder types

Other

Identifiers

NCT01037998

94-09-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.