A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
研究概览
简要总结
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.
详细描述
Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.
Every week that chemotherapy is given, blood tests and vital signs will be taken.
After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.
CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site.
- •ECOG performance status of < 1
- •> 4 weeks since completion of previous chemotherapy
- •> 4 weeks since participation in any investigational drug study
- •Peripheral neuropathy of grade < 1
- •Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.
- •Absolute neutrophil count (ANC) > 1,500/mm3
- •Hemoglobin > 9.0gm/dl
- •Platelets > 100,000/mm3
- •Total bilirubin < 2.0mg/dl
- •AST and alkaline phosphatase < 5 x upper limit of normal (ULN)
- •Albumin > 2.5gm/dl
- •CA 19-9 > 1.5 x ULN
排除标准
- •Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
- •More than one prior chemotherapy treatment
- •Clinically significant cardiac disease
- •Major surgery within 4 weeks of the start of study treatment
- •Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
- •Uncontrolled serious medical or psychiatric illness
- •Pregnant or breast-feeding women
- •Other active malignancy
- •Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome
- •Known severe hypersensitivity to Iressa
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.
- •History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- •Any evidence of clinically active interstitial lung disease
- •Ascites requiring paracentesis
结局指标
主要结局
To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
时间窗: 3 years
次要结局
- To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel