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
- Conditions
- Fluorouracil-resistant advanced colorectal cancer
- Registration Number
- EUCTR2005-003492-20-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1324
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method