Clinical trial NCT01037998: UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer
Official title: Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: adenocarcinoma
non-small-cell lung cancer
gefitinib
UFUR
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2009-12-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To assess and compared the 6-month survival rate of these two arms of treatment.
timeFrame: 6 months
Secondary outcomes:
measure: To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei VGH
Study officials:
affiliation: Chest Department, Taipei VGH
name: Yuh-Min Chen, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: