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 sites1,324 target enrollmentDecember 20, 2004

Overview

Registry

who.int

Start Date

December 20, 2004

End Date

February 28, 2010

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds (UK)

•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:

•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