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 sites1,324 target enrollmentMarch 10, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 10, 2006

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Leeds

•\- 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

•\- 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.