A Randomised Fase I/II Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
研究概览
简要总结
This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to study entry?
- •Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas?
- •Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy?
- •Former treatment with chemotherapeutic agent containing gemcitabine?
- •Is the age of the patient ≥ 18 years?
- •Is the ECOG performance status 0-1?
- •Is the absolute neutrophil count (ANC) ≥ 1.5 x 109/l?
- •Is the platelet count ≥ 75 x 109/l?
- •Is the total bilirubin ≤1.5 x UNL (upper normal limit)?
- •Patient has normal liver function? (If liver metastases are present, there is no upper limit for ALAT/SPGT/alk phosph)?
- •Creatinine clearance ≥ 30 ml/min
- •Is the patient capable of following the treatment and the plan of evaluation?
排除标准
- •CTC Grade 3 hyperlipidaemia (>10.34 mmol/l) in spite of treatment
- •Active former or concurrent history of malignant neoplasm, in the last 2 years?
- •Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial?
- •Pregnant or breast feeding patient (fertile patients must use contraceptives)?
- •Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease)
- •Known hypersensitivity toward one or more of the parts in the treatment?
研究组 & 干预措施
Phase II: Arm A
Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B
干预措施: Everolimus, Cetuximab, Irinotecan (Drug)
Arm B
Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.
干预措施: Capecitabine, Oxaliplatine (Drug)
结局指标
主要结局
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
时间窗: 4 months
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer
时间窗: 4 months
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death
时间窗: 18 months
次要结局
- Survival All events grade 1-5 according to NCI-CTCAE in fase I All Adverse events grade 1-5 according to NCI-CTCAEW in Fase II Correlation between effect of treatment and tumourmarkers Quality of life - EORTC QLQ Time to failure of Strategy(22 months)
研究者
Per Pfeiffer
Professor
Odense University Hospital