Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- tumor response
研究概览
简要总结
The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.
详细描述
For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.
But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.
So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.
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
- •Dated and signed informed concent
- •Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
- •Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
- •Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
- •Age >= 18 years
- •Karnofsky index > 60%
- •Expected live span > 12 weeks
- •Sufficient bone marrow reserve: Granulocytes >= 1.5 x 109/L and Platelets >= 100 x 109/L and Hemoglobin >= 9 g/L
- •Serum Bilirubin < 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
- •AST/ALT < 2.5 x upper normal limit
排除标准
- •Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
- •Pregnancy or lactation
- •Patients able to reproduce that do not adhere to strict contraception
- •Presence of brain metastasis
- •Severe, uncontrolled infection
- •Preexisting peripheral neuropathy > grade I
- •Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
- •Justified disbelief in the compliance of the patient
- •Parallel participation in another clinical trial
结局指标
主要结局
tumor response
时间窗: 12/2009 and end of the study 12/2010
次要结局
- overall survival(12/2009 and end of study 12/2010)
- progression free survival(12/2009 and end of study 12/2010)
- Questionnaire for quality of life(every three weeks)
- Questionnaire for clinical Benefit(every week)
- toxicity / safety(every week)