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

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037998
• Other study ID #: 94-09-03
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: December 22, 2009
• Start date: November 2005
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• UFUR and Iressa
Iressa 250 mg daily plus UFUR 1# bid

Locations

Country	Name	City	State
Taiwan	Taipei VGH	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess and compared the 6-month survival rate of these two arms of treatment.		6 months	No
Secondary	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	Yes