EUCTR2005-004236-40-DE进行中（未招募）不适用
Phase II study: Docetaxel plus Oxaliplatin as second-line therapy in patients with advanced metastatic pancreatic cancer - not available
niversitätsklinikum Ulm0 个研究点目标入组 44 人开始时间: 2007年10月8日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Dated and signed informed consent
- •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 of age
- •Karnofsky index > 60%
- •Expected live span > 12 weeks
- •Sufficient bone marrow reserve:
- •- Granulocytes >= 1.5 x 109/L
- •- Platlets >= 100 x 109/L
- •- Hemoglobin >=9g/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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
- •Dated and signed informed consent
- •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 of age
- •Karnofsky index > 60%
- •Expected live span > 12 weeks
- •Sufficient bone marrow reserve:
- •- Granulocytes >= 1.5 x 109/L
- •- Platlets >= 100 x 109/L
- •- Hemoglobin >=9g/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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
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 metastases
- •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
- •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 metastases
- •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
研究者
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