NCT00234429已完成2 期
A Randomized, Placebo-Controlled, Double-Blind Phase 2b Study of Raltitrexed (Tomudex) and ZD1839 (Iressa) Versus Raltitrexed Alone as Second Line Chemotherapy in Subjects With Colorectal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 74
- 试验地点
- 9
- 主要终点
- Determine the progression free survival
研究概览
简要总结
The primary objective of this study is to compare the activity of raltitrexed and ZD1839 versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by estimating progression free survival (PFS) in each treatment arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 75 years, inclusive
- •histologically-confirmed metastatic colorectal carcinoma; measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST)
- •relapsed after treatment with a fluoropyrimidine-based chemotherapy
- •prior chemotherapeutic regimen for metastatic or locally advanced disease with an interval of at least 4 weeks between the last administration of chemotherapy an the first administration of study treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •life expectancy of at least 12 weeks
排除标准
- •Known severe hypersensitivity to raltitrexed or any of the excipients of this product
- •known severe hypersensitivity to raltitrexed or any of the excipients of this product
- •active infection or uncontrolled diarrhoea
- •cerebral metastasis or meningeal carcinomatosis
- •any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- •simultaneous antitumoral treatment
- •radiotherapy within 2 weeks before entry into the study
- •other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
- •significant clinical disorder or laboratory finding (leukocyte count less than 3.0 x 109 /litre (L) or platelets less than 100 x 109 /L; serum total bilirubin more than 2.0 mg/dl; as judged by investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); creatinine clearance ≥ 65ml/min (according to Cockcroft-Gault formula); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range (ULRR) if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases)
- •pregnancy or breast feeding (women of child-bearing potential)
- •concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or ST John's Wort;
- •Treatment with a non- approved or investigational drug within 30 days before Day 1 of study treatment
结局指标
主要结局
Determine the progression free survival
次要结局
- Determine objective tumor response
研究者
研究点 (9)
Loading locations...
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