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

• Conditions: Metastatic or locally recurrent colorectal cancer in genetically unselected patients, followed by recruitment of patients selected for microsatellite positive tumours; MedDRA version: 9.1Level: LLTClassification code 10010035Term: Colorectal cancer stage IV; MedDRA version: 9.1Level: LLTClassification code 10010030Term: Colorectal cancer recurrent

• Registration Number: EUCTR2006-006073-24-GB
• Lead Sponsor: Royal Marsden Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

•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)
ii.Serum alanine transaminase (ALT) = 5 x ULN
iii.Serum alkaline phosphatase (ALP) < 5 x ULN
iv.Total serum bilirubin < 1.5 x ULN
v.Prothrombin time (PT) = 1.5 x ULN
•Adequate haematological function:
i.Absolute neutrophil count (ANC) =1500/µL
ii.Platelets =100, 000/µL
iii.Haemoglobin =9.0 g/dL
•Serum creatinine clearance of greater than 50ml/min according to the Cockcroft-Gault calculation or measured glomerular filtration rate of >50ml/min
•Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
•Prior radiotherapy or colostomy are allowed
•Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects prior to enrolment
•For Cohort B, all patients must have tumours which are MSI positive by IHC

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified