EUCTR2006-001238-41-IT进行中（未招募）不适用
Phase II trial of Erlotinib in combination with increasing dose of gemcitabine given as fixed dose rate infusion in advanced pancreatic cancer. - tarcevapancreas
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2007年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-Histologically confirmed unresectable advanced or metastatic pancreatic adenocarcinoma
- •-Measurable or evaluable disease. To be considered evaluable for complete or partial response patients must have at least one measurable lesion.
- •-age 18-70 yrs
- •-PS 0-1 (ECOG scale)
- •-No previous chemotherapy for advanced/metastatic pancreatic carcinoma. Previous adjuvant treatment is allowed.
- •-Patients must have no uncontrolled concurrent serious medical illness.
- •-Investigations including chest x-ray, CT scan of abdomen and pelvis and other scans (as clinically indicated), have to be performed within 28 days prior to start the treatment.
- •-Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to start the treatment:
- •ANC> 1500/l
- •PLT> 100000/l
- •Creatinine< 1.5 times the ULN
- •Total Bilirubine< 2 times the ULN
- •GOT< 2 times the ULN or < 5 times in case of liver metastasis
- •GPT< 2 times the ULN or < 5 times in case of liver metastasis
- •-Written informed consent
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-history of malignancies in the last 5 years
- •-significant history of cardiac disease, uncontrolled high blood pressure, instable angina, congestive heart failure, myocardial infarction within the last year.
- •-Serious active infection or serious underling medical conditions
- •-Known CNS metastases. CT scan of brain is not required unless there is clinical suspicion of CNS involvement
- •-GI tract disease resulting in an inability to take oral medication or a requirement of IV alimentation, prior surgery procedure affecting absorption, uncontrolled inflammatory GI disease
- •-Serious active infection or serious underlying medical conditions that would impair the ability of the patient to receive the treatment.
- •-Prior treatment with inhibitors of EGFR
研究者
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