CINATRA: Chromosomal Instability and Anti-Tubulin Response Assessment: A Phase II Study of Epothilone B in Metastatic Colon Carcinoma in patients with Microsatellite Instability or Chromosomal Instability - CINATRA

Royal Marsden Hospital0 sites110 target enrollmentMarch 14, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Royal Marsden Hospital

•Histologically confirmed metastatic or locally recurrent carcinoma of the colon or rectum
•Prior therapy with oxaliplatin, 5\-fluoropyrimidine and irinotecan
•Availability of paraffin embedded tumour tissue for analysis of MSI status and CIN
•Male or female
•18 years of age or older
•Life expectancy of 12 weeks or greater
•ECOG performance status 0 or 1
•Clinically and/or radiographically documented measurable disease
•Adequate liver function:
•i.Serum aspartate transaminase (AST) \= 5 x upper limit of normal (ULN)

•Persistent toxicity from previous treatment. Neurotoxicity from prior oxaliplatin must have resolved to at least grade 1\.
•Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, or adequately treated in\-situ cervical cancer
•Any of the following within the 12 months prior to study drug administration
•i.Myocardial infarction or severe/unstable angina,
•ii.Coronary/peripheral artery bypass graft
•iii.Symptomatic congestive heart failure
•iv.Cerebrovascular accident or transient ischemic attack
•v.Pulmonary embolism
•Pregnancy or breastfeeding
•Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study