EUCTR2006-006073-24-GBActive, not recruitingNot Applicable
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 enrollmentStarted: March 14, 2008Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
Similar Trials
Unknown
Not Applicable
Application of UCAD for Diagnosing Urothelial Carcinoma.Chromosomal AbnormalityUrothelial CarcinomaDiagnoses DiseaseUrine MarkingNCT03998371Changhai Hospital300
Withdrawn
Not Applicable
Chromosomal instability as indicator for the treatment of progressive mucosal lesions of the oral cavity: a prospective study.hyperkeratosishyperplasiamild to moderate dysplasiapremalignant laesion.1002765610019190NL-OMON40192Medisch Universitair Ziekenhuis Maastricht374
Recruiting
Not Applicable
Application of Chromosomal Instability in Early Diagnosis of Biliary Tract CarcinomaBiliary Tract CarcinomaNCT05845554Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University300
Unknown
Not Applicable
Chromosomal Instability in Ovarian CancerHigh-grade Serous Ovarian CarcinomaChromosomal InstabilitySomatic Copy Number DistortionSurvival OutcomesMinimal Residual LesionsProgression-free SurvivalOverall SurvivalEpithelial Ovarian CancerNCT05310357Lei Li300
Unknown
Not Applicable
A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-upBiliary Tract NeoplasmsPancreatic CarcinomaGallbladder CancerPancreatic Head CarcinomaNCT05237193Xinhua Hospital, Shanghai Jiao Tong University School of Medicine400