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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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PICCOLO
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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
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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93248876
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EudraCT
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2005-003492-20
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MREC N° |
06/Q0906/38
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UKCRN ID |
1468
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WHO ID
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Research Summary
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PICCOLO has two separate clinical objectives. These are:
Objective 1 (irinotecan modulation with ciclosporin): to establish whether the toxicity of irinotecan therapy is reduced, without loss of efficacy, by modulation with ciclosporin
Objective 2 (addition of panitumumab): to establish whether, in patients with K-RAS wild-type tumours, the efficacy of irinotecan therapy is improved by the addition of panitumumab
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Colon
Rectum
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Phase |
III
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Current Status
| Open |
| Closure Date | 31/05/2010 |
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Sample Size
| 1324 |
| Accrual to Date |
 73% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England (also active in Scotland and Wales) |
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Open to new sites
| Yes, within and outside lead country |
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Additional Information
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If you are a patient or relative this link http://www.cancerhelp.org.uk/trials/trials/trial.asp?=&trialno=9302 will take you to a description of this trial in plain English on CancerHelp UK
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Main Inclusion Criteria
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Patient Selection
The Cancer Diagnosis
• Confirmed advanced colorectal adenocarcinoma:
o either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical/radiological evidence of advanced/ metastatic disease
o or histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical/radiological evidence of colorectal primary tumour
• Unidimensionally measurable disease (RECIST criteria, see Appendix 1)
• Not known to have CNS metastases or carcinomatous meningitis
Previous Anticancer Treatment
• Patient must have had prior fluoropyrimidine +/- oxaliplatin therapy, with disease progression during or after that treatment:
o adjuvant therapy and/or prior therapy for advanced disease may have been given.
o if disease has progressed after but not during prior therapy, the treating consultant should be satisfied that further fluoropyrimidine (+/- oxaliplatin) therapy is not appropriate.
o if the only prior chemotherapy was given adjuvantly, progression should have occurred during or <3 months after completing the adjuvant course, and the treating consultant should be satisfied that further fluoropyrimidine (+/- oxaliplatin) therapy is not appropriate
• No previous treatment with irinotecan may have been given
• Prior anti-EGFR therapy (cetuximab; panitumumab) and/or bevacizumab is acceptable, but patients with a prior anaphylactic reaction to cetuximab should not be entered.
• Please note the minimum acceptable time intervals from the end of previous therapy to the planned start of PICCOLO treatment:
o Capecitabine: 14 days
o All other licensed cytotoxic drugs: 21 days
o Prior cetuximab, panitumumab or bevacizumab: 21 days
o Any experimental anticancer drug therapy including antibodies: 42 days
Note also that PICCOLO treatment must start as soon as possible (maximum 14 days) after randomisation.
• Prior radical pelvic radiotherapy is not an absolute contraindication, however patients with ongoing radiotherapy toxicity, especially diarrhoea, should not be entered into PICCOLO.
Patient Fitness and Co-morbidity
• WHO performance status of 0, 1 or 2, with estimated life expectancy of at least 12 weeks
• Full blood count:
o Hb ≥10.0 g/dl; WBC ≥3.0 x109/l; Plts ≥100 x109/l
• Renal biochemistry:
o GFR calculated by the Cockcroft formula ≥50 ml/min, or measured GFR (EDTA or 24hr creatinine clearance) ≥60ml/min.
• Hepatobiliary function:
o ALP ≤ 5 x Upper Limit of Normal (ULN), and AST or ALT ≤ 2.5 x ULN
o bilirubin ≤ 25 umol/l, and no clinical or radiological evidence of biliary obstruction
o no known history of Gilbert’s syndrome
• Medical comorbidity:
o no ongoing requirement for for ciclosporin or a contraindicated concomitant medication (see section 6.6). Short-course antibiotics or antifungals are acceptable if they will finish > 5 days before start of PICCOLO therapy.
o no concurrent or previous other cancer that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer acceptable; for other cases please discuss with CTRU)
o no other serious medical condition: e.g.: major surgery within preceding four weeks, unresolved bowel obstruction; uncontrolled infection, uncontrolled chronic enteropathy (e.g. Crohn’s disease, ulcerative colitis), or chronic diarrhoea (>4 stools per day) of any cause
o no clinical or radiological evidence of interstitial pneumonitis, pulmonary fibrosis, pleural effusion or ascites causing grade >2 dyspnea
Other Factors
• Aged ≥18 years
• Capable of oral self-medication, reporting toxicity and completing QoL questionnaires
• If female and of childbearing potential, must:
o have a negative pregnancy test within 72 hours prior to trial entry, and not be breastfeeding
o 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:
o 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
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Main Exclusion Criteria
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See inclusion criteria
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Chief Investigator(s)
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| Prof Matt Seymour |
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Further details, please contact
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Mr Marc Jones
CTRU
University of Leeds
Woodhouse Lane
Leeds
West Yorkshire
LS2 9JT
UNITED KINGDOM
Tel: 0113 343 1495
M.Jones@leeds.ac.uk
| Ms Catherine Olivier
CTRU
University of Leeds
Woodhouse Lane
Leeds
West Yorkshire
LS2 9JT
UNITED KINGDOM
Tel: 0113 3431494
c.olivier@leeds.ac.uk
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Funder(s) |
Amgen Ltd
Cancer Research UK
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Sponsor(s) |
University of Leeds
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