Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- To assess and compared the 6-month survival rate of these two arms of treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
A
Iressa 250 mg daily treatment plus UFUR twice daily treatment
干预措施: UFUR and Iressa (Drug)
结局指标
主要结局
To assess and compared the 6-month survival rate of these two arms of treatment.
时间窗: 6 months
次要结局
- 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)