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临床试验/ISRCTN93248876
ISRCTN93248876已完成3 期

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

niversity of Leeds (UK)0 个研究点目标入组 1,324 人开始时间: 2004年12月20日最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,324
研究概览入排标准研究者记录与标识符相似试验

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •Current information as of 28/09/10:
  • •1. Advanced colorectal cancer defined in either of the following ways:
  • •1.1. Previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical/radiological evidence of advanced/metastatic disease
  • •1.2. Histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical/radiological evidence of colorectal primary tumour
  • •2. Unidimensionally measurable disease (please refer to RECIST criteria)
  • •3. Prior fluoropyrimidine therapy, +/- oxaliplatin, +/- bevacizumab together with disease progression during or after that treatment. Adjuvant therapy and/or prior therapy for advanced disease may have been given
  • •4. Able to start trial treatment within 14 days of randomisation
  • •5. WHO performance status of 0, 1 or 2 and a life expectancy of at least 12 weeks
  • •6. Aged =18 years at time of consent
  • •7. Adequate full blood count, defined as:
  • •7.1. Haemoglobin (Hb) >10.0 g/dl
  • •7.2. While Blood Count (WBC) >3.0 x109/l
  • •7.3. Platelets >100 x109/l
  • •8. Adequate renal biochemistry, defined as:
  • •8.1. Glomerular Filtration Rate (GFR) calculated/measured by either
  • •8.1.1. Cockcroft formula >50 ml/min
  • •8.1.2. EDTA clearance >60ml/min
  • •8.2. Creatinine clearance measured by 24hr urine collection >60ml/min
  • •9. Adequate hepatobiliary function
  • •9.1. Total bilirubin < 25 umol/l
  • •9.2. Alkaline Phosphatase (ALP) no more than 5x upper limit of normal (ULN)
  • •9.3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) no more than 2.5 X ULN
  • •9.4. No clinical or radiological evidence of biliary obstruction
  • •9.5. No known history of Gilbert?s syndrome
  • •10. If female and of child bearing potential, must have a negative pregnancy test within 72 hours before trial entry, is not breastfeeding and has agreed to take adequate, medically approved, contraceptive precautions (oral or barrier contraceptives under the supervision of a General Practioner or Family Planning Clinic) during and for 6 months after study treatment
  • •11. If male with a partner of childbearing age, must agreed to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptives under the supervision of a General Practioner or Family Planning Clinic) during and for 6 months after study treatment
  • •12. Capable of reliable oral self-medication and toxicity reporting
  • •13. Capable of completing Quality of Life questionnaires (The baseline Quality of Life questionnaire must be completed before randomisation)
  • •14. In the opinion of the investigator: Is the patient capable of giving informed consent?
  • •Initial information at time of registration:
  • •1. Confirmed advanced colorectal adenocarcinoma
  • •2. Unidimensionally measurable disease (RECIST criteria)
  • •3. 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)

排除标准

  • •Current information as of 28/09/10:
  • •1. Previous treatment with irinotecan
  • •2. Patient has received any of the following:
  • •2.1. Capecitabine within 14 days prior to randomisation
  • •2.2. All other licensed cytotoxic drugs within 21 days prior to randomisation
  • •2.3. Prior cetuximab, panitumumab or bevacizumab within 21 days prior to randomisation
  • •2.4. Any experimental anticancer drug therapy including antibodies within 42 days prior to randomisation
  • •3. Prior anaphylactic allergic reaction to any anti-EGFR
  • •4. Ongoing requirement for ciclosporin or any contraindicated concomitant medication, namely diltiazem, verapamil, amiodarone or fluvoxamine. Note: any prescribed short-courses of antifungals or antibiotics would not make a patient ineligible but should be completed 5 days before starting trial therapy.
  • •5. Concurrent or previous other cancer (excluding non-melanomatous skin cancer), unresolved bowel obstruction or uncontrolled infection, uncontrolled chronic enteropathy (e.g. Crohn?s disease, ulcerative colitis), or chronic diarrhoea (=4 stools per day) of any cause
  • •6. Major thoracic or abdominal surgery within the last 4 weeks
  • •7. Known CNS metastases, carcinomatous meningitis or a recent history of seizures
  • •8. Clinical/radiological evidence of interstitial pneumonitis, ulmonary fibrosis, pleural effusion or ascites causing grade =2 dyspnea
  • •9. Any other condition, which, in the investigator?s opinion would make the patient unsuitable for participation in the trial
  • •Initial information at time of registration:
  • •1. Any previous treatment with irinotecan
  • •2. Experimental drug therapy or any antibody therapy other than cetuximab, within 6 weeks before study enrolment
  • •3. Systemic chemotherapy and/or cetuximab within 28 days before study enrollment
  • •4. Prior anaphylactic allergic reaction to cetuximab
  • •5. Ongoing requirement for ciclosporin or any contraindicated concomitant medication, namely: diltiazem, verapamil, amiodarone or fluvoxamine
  • •6. Concurrent or previous other cancer (excluding non-melanomatous skin cancer), major thoracic or abdominal surgery within preceding four 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
  • •7. Known CNS metastases, carcinomatous meningitis or recent history of seizures
  • •8. Clinical or radiological evidence of interstitial pneumonitis, pulmonary fibrosis, pleural effusion or ascites causing grade =2 dyspnea
  • •9. Incapable of reliable oral self-medication
  • •10. Any other condition, which, in the investigator?s opinion would make the patient unsuitable for participation in the trial

研究者

发起方
niversity of Leeds (UK)

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