A randomised trial assessing the role of two new agents in the management of advanced colorectal cancer

Medical Research Council (MRC) Clinical Trials Unit (UK)0 sites2,100 target enrollmentApril 6, 2000

Overview

2005 ASCO Annual Meeting Proceedings abstract in http://meeting.ascopubs.org/cgi/content/abstract/23/16_suppl/3518 2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17630037 3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18509181 4. 2009 results on the association of molecular markers with toxicity outcomes in http://www.ncbi.nlm.nih.gov/pubmed/19858398 5. 2009 results on the effect of KRAS and BRAF mutations on efficacy of treatment agents in http://www.ncbi.nlm.nih.gov/pubmed/19884549

Registry

who.int

Start Date

April 6, 2000

End Date

December 31, 2003

Last Updated

7 years ago

Study Type

Interventional

Sponsor

Medical Research Council (MRC) Clinical Trials Unit (UK)

•1\. Histologically confirmed adenocarcinoma of the colon or rectum
•2\. Inoperable disease (either locally advanced, recurrent or metastatic and not suitable for curative surgery or radiotherapy)
•3\. Measurable or evaluable disease
•4\. World Health Organization (WHO) performance status zero to two
•5\. Fit, able and willing to undergo any of the possible trial treatments and to comply with the quality of life questionnaires

•1\. White Blood Cells (WBC) less than 4 x 10^9/l
•2\. Platelets less than 150 x 10^9/l
•3\. Bilirubin more than 1\.25 x Upper Limit of Normal (ULN)
•4\. Alkaline phosphatase more than 3 x ULN
•5\. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than 3 x ULN
•6\. Renal impairment (calculated Creatinine Clearance \[CrCl] less than 60 ml/min, or measured Glomerular Filtration Rate \[GFR] below normal range)
•7\. Serious uncontrolled medical co\-morbidity