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

Phase 2
18 Years
Not Enrolling
Non-Small-Cell Lung Cancer

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Yuh-Min Chen, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chest Department, Taipei VGH


Taiwan: Department of Health

Study ID:




Start Date:

November 2005

Completion Date:

December 2009

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • adenocarcinoma
  • non-small-cell lung cancer
  • gefitinib
  • UFUR
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms