NCT00440167Unknown3 期
Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer
PD Dr. med. Volker Heinemann0 个研究点目标入组 280 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 280
- 主要终点
- TTF2
研究概览
简要总结
This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)
- •No option for resection with curative intent
- •At least one measurable or not measurable lesion (according to RECIST)
- •No previous chemotherapy or other systemic tumor therapy
- •No previous radiation
- •Performance-Status 0-2 according to WHO/ECOG
- •Life expectancy of at least 3 months
- •Adequate kidney-, liver- and bone marrow function, defined as
- •Absolute neutrophil count * 1,5 x 109/l
- •Hemoglobin * 8 g/dl
- •Thrombocytes * 100 x 109/l
- •Bilirubin * 2 x upper norm (with liver mets < 5-fold)
- •Serum Creatinine * 1,25 x upper norm
- •Creatinine clearance > 30 ml/min (Cockroft/Gault)
- •Transaminases * 2,5 x upper norm (with liver mets < 5-fold)
- •Possibility of regular long-term follow-up
- •Negative pregnancy test in women at childbearing age
- •All patients must have signed an informed consent before study entry.
排除标准
- •Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri
- •Clinically unstable CNS-metastases
- •Known hypersensitivity against study medication
- •Severe impairment of renal function (creatinine clearance < 30 ml/min)
- •Severe impairment of liver function (bilirubin > 2,0 x above upper norm, transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm)
- •Clinically relevant disease of the cardiovascular system or other vital organs
- •Known polyneuropathy
- •Known DPD-deficiency (screening not required)
- •Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin
- •Pregnancy, lactation or lack of reliable contraception in women at childbearing age
- •Mental disease, drug- or alcohol abuse
- •Participation in another clinical trial within the last 4 weeks
- •All other diseases which may prevent adequate participation in the trial
- •Indication of lack of compliance with study regulations
研究组 & 干预措施
Arm A
Active Comparator
干预措施: Capecitabine (Drug)
Arm A
Active Comparator
干预措施: Erlotinib (Drug)
Arm B
Active Comparator
干预措施: Gemcitabine (Drug)
Arm B
Active Comparator
干预措施: Erlotinib (Drug)
结局指标
主要结局
TTF2
时间窗: approximate 6 months after first line treatment
Time to treatment failure, after 2nd line (crossover) therapy
次要结局
- TTF1(approximate 6 months after randomization)
- Remission Rate(approximate 6 months after randomization)
- Overall Survival(42 months after randomization)
- Clinical Benefit Response(approximate 6 months after randomization)
- Tumor marker CA19-9 characteristics(approximate 6 months after randomization)
- Quality of Life(approximate 6 months after randomization)
- Toxicity(approximate 6 months after randomization)
研究者
PD Dr. med. Volker Heinemann
Sponsor Delegatated Person
Ludwig-Maximilians - University of Munich
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