EUCTR2015-004028-69-DE进行中（未招募）1 期
5-Fluorouracil (5-FU), folinic acid and irinotecan (FOLFIRI) versus 5-FU and folinic acid as second-line chemotherapy in patients with biliary tract cancer (IRIBIL): a randomized open-label phase 2 study
Goethe-Universität Frankfurt, PD Fabian Finkelmeier0 个研究点目标入组 56 人开始时间: 2016年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
- •Written informed consent granted prior to initiation of any study specific screening procedures
- •Patients with histologically confirmed CCA or GB-CA not suitable for resection or metastatic
- •Progressive disease undergoing a systemic chemotherapy with a platin-derivate (Oxaliplatin, Cisplatin or Carboplatin) or progressive disease within 3 months after cessation of chemotherapy
- •Age >= 18 years
- •Performance status ECOG 0-2
- •Normal organ and bone marrow function defined as:
- •o Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count >75,000/mm3, hemoglobin >9 g/dL
- •o INR = 1.5
- •o Hepatic: AST or ALT < 5 x ULN, bilirubin = 2 mg/dl
- •o Renal: serum creatinine < 1.5 x ULN
- •Child Pugh stage A in patients with cirrhosis
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the randomization
- •Male or female patients of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
- •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 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •CCA or GB-CA amendable for surgical resection
- •Prior radiation therapy, chemoradiation, transarterial chemoembolisation (TACE), Radiofrequency ablation (RFA) or selective intraarterial Radiotherapy (SIRT) within the last 3 months, radiation of symptomatic bone metastasis is allowed
- •Concomitant photodynamic therapy or intraductal radiofrequency ablation within the last 8 weeks
- •Child Pugh stage B or C (> 6 points) in patients with cirrhosis (Appendix 21.3)
- •Massive, uncontrolled ascites
- •Systemic anticancer chemotherapy other than Gemcitabin and a platin derivate (Cisplatin, Carboplatin or Oxaliplatin)
- •Cardiac disease: congestive heart failure > class II NYHA
- •Known uncontrolled brain metastasis
- •History of bone marrow or organ allograft
- •Active clinically serious infections > CTCAE grade 2 beside of chronic hepatitis C virus infection
- •Major surgery within 4 weeks of first dose of study drug, port implantation is allowed
- •Known or suspected allergies to 5-FU, folinic acid or irinotecan
- •Previous cancer that is distinct in primary site or histology from CCA or GB-CA except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry
- •Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study
- •Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
- •Pregnancy or breast feeding women
- •Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
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