Back to resultsUFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer
Primary Purpose
Non-Small-Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
UFUR and Iressa
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring adenocarcinoma, non-small-cell lung cancer, gefitinib, UFUR
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.
Sites / Locations
- Taipei VGH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A
B
Arm Description
Iressa 250 mg daily treatment plus UFUR twice daily treatment
Gefitinib 250 mg daily treatment
Outcomes
Primary Outcome Measures
To assess and compared the 6-month survival rate of these two arms of treatment.
Secondary Outcome Measures
To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.
Full Information
NCT ID
NCT01037998
First Posted
May 27, 2008
Last Updated
December 22, 2009
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01037998
Brief Title
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
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer
Keywords
adenocarcinoma, non-small-cell lung cancer, gefitinib, UFUR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Iressa 250 mg daily treatment plus UFUR twice daily treatment
Arm Title
B
Arm Type
No Intervention
Arm Description
Gefitinib 250 mg daily treatment
Intervention Type
Drug
Intervention Name(s)
UFUR and Iressa
Other Intervention Name(s)
UFUR
Intervention Description
Iressa 250 mg daily plus UFUR 1# bid
Primary Outcome Measure Information:
Title
To assess and compared the 6-month survival rate of these two arms of treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To assess and compared the progression-free survival, overall survival, the response rate, and the toxicity profiles of these two arms of treatment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuh-Min Chen, MD, PhD.
Organizational Affiliation
Chest Department, Taipei VGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei VGH
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
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UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer
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