EUCTR2005-003492-20-GB进行中（未招募）不适用
A randomised clinical trial of treatment for fluorouracil-resistant advanced colorectal cancer comparing standard single-agent irinotecan versus irinotecan plus panitumumab and versus irinotecan plus ciclosporin - PICCOLO: Panitumumab, Irinotecan & Ciclosporin in Colorectal cancer therapy
niversity of Leeds0 个研究点目标入组 1,324 人开始时间: 2006年3月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,324
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
- •- Confirmed advanced colorectal adenocarcinoma:
- •either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical/radiological evidence of advanced/ metastatic disease OR histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical/radiological evidence of colorectal primary tumour.
- •- Unidimensionally measurable disease
- •- Prior fluoropyrimidine +/- oxaliplatin therapy, +/- bevacizumab with disease progression during or after that treatment. Adjuvant therapy and/or prior therapy for advanced disease may have been given
- •- At least 14 days from last capecitabine, 21 days from all other licensed cytotoxic drugs and panitumumab, cetuximab and bevacizuab, 42 days from last experimental anticancer drug therapy incl. antibodies.
- •- WHO performance status of 0, 1 or 2, with estimated life expectancy of at least 12 weeks
- •- Aged =18 years
- •- Adequate full blood count: Hb =10.0 g/dl; WBC =3.0x109/l; Plts =100x109/l
- •- Adequate renal biochemistry: GRF calculated by the Cockcroft formula =50 ml/min, or measured by EDTA clearance =60 ml/min
- •- Adequate hepatobiliary function: total bilirubin =25 umol/l; ALP =5x ULN; AST or ALT =2.5 x ULN; no clinical or radiological evidence of biliary obstruction; no know history of Gilbert's syndrome
- •- If female and of childbearing potential, must: have a negative pregnancy test within 72 hours prior to trial entry, and not breastfeeding; agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during and for 6 months after study treatment
- •- If male with a partner of childbearing potential, must: agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during and for 6 months after study treatment
- •- Capable oral self medication , reporting toxicities & completing QoL questionnaires
- •- Signed, informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any previous treatment with irinotecan
- •- Prior anaphylactic reaction to cetuximab
- •- Ongoing requirement for ciclosporin or any contraindicated concomitant medication*
- •- Concurrent or previous other cancer that could confuse diagnosis, major surgery within preceding 4 weeks, unresolved bowel obstruction or uncontrolled infection, chronic enteropathy (e.g. Crohn’s disease, ulcerative colitis), or chronic diarrhoea (=4 stools per day) of any cause
- •- Clinical or radiological evidence of interstitial pneumonitis, pulmonary fibrosis, pleural effusion or ascites causing grade =2 dyspnea.
- •- CNS metastases or carcinomatous menigitis
- •Ongoing radiotherapy toxicity
- •*Note: any prescribed short-courses of antifungals or antibiotics would not make a patient ineligible but should be completed 5 days before the starting of trial therapy.
研究者
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