CINATRA: Chromosomal Instability and Anti-Tubulin Response Assessment

Not Applicable

Completed

• Conditions: Cancer; Metastatic colorectal cancer; Colorectal cancer

• Registration Number: ISRCTN58864837
• Lead Sponsor: The Royal Marsden Hospital NHS Foundation Trust (UK)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23801302 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-21
• Study Completion: 2012-05-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. Male or female
2. 18 years of age or older
3. Histologically confirmed metastatic or locally recurrent carcinoma of the colon or rectum
4. Prior therapy with oxaliplatin, a fluoropyrimidine, and irinotecan for colorectal cancer. If a patient has previously received raltitrexed, this would be considered as equivalent to fluoropyrimidine treatment
5. Availability of paraffin embedded tumour tissue for analysis of microsatellite instability (MSI) status and chromosomal instability (CIN)
6. Life expectancy of 12 weeks or greater
7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
8. Clinically and/or radiographically documented measurable disease according to the Response Evaluation Criteria In Solid Tumours (RECIST), with at least one unidimensionally lesion measuring 10mm or greater by spiral CT or 20mm or greater by conventional (non-spiral) computerised tomography (CT)
9. Adequate liver function:
9.1. Serum aspartate aminotransferase (AST) less than or equal to 5 x upper limit of normal (ULN)
9.2. Serum alanine aminotransferase (ALT) less than or equal to 5 x ULN
9.3. Serum alkaline phosphatase (ALP) less than 5 x ULN
9.4. Total serum bilirubin less than 1.5 x ULN
9.5. Prothrombin time (PT) less than or equal to 1.5 x ULN
10. Adequate haematological function:
10.1. Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L
10.2. Platelets greater than or equal to 100 x 10^9/L
10.3. Haemoglobin greater than or equal to 9.0 g/dL
11. Serum creatinine clearance of greater than 50 ml/min according to the Cockcroft-Gault calculation or measured glomerular filtration rate of greater than 50 ml/min
12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
13. Prior radiotherapy or colostomy are allowed. A marker lesion may not be in a previously irradiated area, unless there has been documented disease progression in that area since radiotherapy.
14. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects prior to enrolment
15. For Cohort B, all patients must have tumours which are microsatellite instability (MSI) positive by immunohistochemistry (IHC)
16. Patients must be willing to undertake adequate contraceptive methods or remain sexually abstinent for the duration of study treatment and for at least 28 days after receiving the last dose of study drug

Exclusion Criteria

1. Persistent toxicity from previous treatment. Neurotoxicity from prior oxaliplatin must have resolved to at least grade 1.
2. Diagnosis of or treatment for 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
3. Any of the following within the 12 months prior to study drug administration:
3.1. Myocardial infarction or severe/unstable angina
3.2. Coronary/peripheral artery bypass graft
3.3. Symptomatic congestive heart failure
3.4. Cerebrovascular accident or transient ischaemic attack
3.5. Pulmonary embolism
4. Pregnancy or breastfeeding
5. 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
6. Clinically significant neuropathy that could be worsened by study treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Twelve-week progression free survival (PFS). This will be measured by comparing a CT scan of the thorax/abdomen and pelvis at baseline (Within 28 days of starting treatment) to a second CT scan performed after 12 weeks from trial registration, evaluated by RECIST criteria.