In metastatic colorectal cancer patients with systemic inflammation, is daily simvastatin feasible and safe to add to standard chemotherapy?

niversity of Sydney0 sites10 target enrollmentFebruary 5, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 5, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•Patients must fulfill ALL of the following criteria to be eligible for admission to the study:
•\* Radiological or pathologically confirmed metastatic colorectal cancer
•\* Measurable or evaluable disease
•\* Eligible for XELOX, mFOLFOX6, or FOLFIRI plus bevacizumab in accordance with local standards of care and pharmaceutical benefits scheme approvals
•\* Evidence of systemic inflammation \- NLR \> or \= 5
•\* WHO performance status of 0, 1 or 2
•\* Adequately recovered from recent surgery. At least 4 weeks must have elapsed from major surgery.
•\* Life expectancy of \> 3 months
•\* Hematology performed within 28 days of starting study treatment and with values within the ranges specified below
•\- Absolute granulocytes/neutrophils \> 1\.5 x 109 /L

•Patients who fulfill any of the following criteria are not eligible for admission to the study:
•\* Prior chemotherapy for metastatic colorectal cancer or adjuvant chemotherapy completed in the last 6 months
•\* Radiotherapy within 28 days prior to enrolment or not recovered from a radiotherapy course
•\* A history of other malignancies with the exception of: adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, or other solid tumours curatively treated with no evidence for \> 3 years.
•\* Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation). History of a significant bleeding event or felt by the investigator to be at risk of such events.
•\* Significant vascular disease (e.g. aortic aneurysm requiring surgical intervention).
•\* Peripheral arterial thrombosis or other arterial thrombotic events within 6 months
•prior to commencement of study treatment.
•\* Inadequately controlled hypertension (defined as values consistently 150/100 mmHg despite use of at least three standard antihypertensive medications).
•\* Prior history of hypertensive crisis or hypertensive encephalopathy.