NCT00478049已完成3 期
A Randomized, Open Label, Parallel Group, Regional, Multicenter, Phase III Study of Oral Gefitinib (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer Who Have Previously Received Platinum Based Chemotherapy (ISTANA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors
研究概览
简要总结
This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.
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
- •Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma.
- •WHO Performance status 0-2
- •NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- •Life expectancy of 12 weeks.
排除标准
- •ALT/AST: >2.5x ULRR if no demonstrable liver metastases or greater than 5 x ULRR in the presence of liver.
- •Inadequate bone marrow function; Absolute neutrophil count: <1.5 x 109/L, Platelets: < 100 x 109/L
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of skin or cervical cancer in situ
研究组 & 干预措施
1
Active Comparator
Docetaxel
干预措施: Docetaxel (Drug)
2
Experimental
Gefitinib
干预措施: Gefitinib (Drug)
结局指标
主要结局
Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors
时间窗: Survival
次要结局
- To compare the overall objective tumor response rates between patients on gefitinib or on docetaxel by overall objective tumor response (complete response (CR) + partial response (PR)) using RECIST criteria.(Survival)
- To compare changes in quality of life (QoL) between patients on gefitinib or on docetaxel by QoL as measured by the FACT-L total score(Every Visit)
- For those patients who are symptomatic at baseline to compare improvement in symptom control between patients on gefitinib or on docetaxel by the FACT-L LCS (Functional Assessment of Cancer Therapy - Lung Lung Cancer Subscale).(Each Visit)
- To compare the safety and tolerability of gefitinib and of docetaxel by Frequency and severity of adverse events (AEs) and laboratory parameters.(Every Visit)
研究者
研究点 (1)
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