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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: UFUR and Iressa

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 112
    • Taipei VGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Iressa 250 mg daily treatment plus UFUR twice daily treatment	Drug: UFUR and Iressa; Iressa 250 mg daily plus UFUR 1# bid; Other Names: UFUR
No Intervention: B; Gefitinib 250 mg daily treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess and compared the 6-month survival rate of these two arms of treatment.	6 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Yuh-Min Chen, MD, PhD., Chest Department, Taipei VGH

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 22, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: gefitinib; adenocarcinoma; non-small-cell lung cancer; UFUR
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: 94-09-03