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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei VGH | Taipei City |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
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 |
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