Phase II Trial of PTK787/ZK222584 in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Who Failed First-Line Gemcitabine Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 7
- 主要终点
- To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
研究概览
简要总结
The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.
In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.
详细描述
This is an open-label, phase II multi-center therapeutic trial investigating the efficacy and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. The primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age > 18
- •Zubrod performance status of 0 - 2
- •Histological or cytological diagnosis of pancreatic adenocarcinoma
- •Measurable or evaluable disease determined as per RECIST criteria
- •Life expectancy > 12 weeks
- •Written informed consent
- •Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.
排除标准
- •Islet cell or neuroendocrine carcinomas of the pancreas.
- •History or presence of central nervous system disease.
- •Patients with a history of another primary malignancy < 5 years
- •Prior chemo therapy < 21 days prior to registration.
- •Prior biologic or immunotherapy < 14 days prior to registration
- •Prior full field radiotherapy < 28 days or limited field radiotherapy < 14 days prior to registration.
- •Major surgery < 28 days prior to registration.
- •Patients who have received investigational drugs < 28 days prior to registration.
- •Prior therapy with anti-VEGF agents.
- •Pleural effusion or ascites that causes respiratory compromise.
- •Female patients who are pregnant or breast feeding.
研究组 & 干预措施
Vatalanib
Administered orally, twice daily: after enrollment - first week 250 BID, second week 500 BID, then 750 BID thereafter.
干预措施: PTK787/ZK222584 (Drug)
结局指标
主要结局
To evaluate the 6-month survival rate and time to progression in pancreatic cancer patients treated with PTK787/ZK222584.
时间窗: DSMC Schedule
The Data Safety Monitoring Board met twice yearly while the study was active (2006-2008) to review data and each of the primary and secondary objectives. Safety Issue: the only endpoint/outcome measure that was a safety issue was the second one (safety and tolerability of PTK)
次要结局
- To assess the response rates of patients treated with PTK787/ZK222584.(DSMC Schedule)
- To evaluate DCE-MRI as a surrogate of response to PTK787/ZK222584 therapy in pancreatic cancer patients.(DSMC Schedule)
- To perform analysis of tissue, blood and plasma markers that may be helpful in assessing the likelihood of benefit from PTK787/ZK222584 therapy.(DSMC Schedule)