Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer

Exclusion Criteria

• •Untreated central nervous system (CNS) metastases; patients may have CNS metastases from any timeframe as long as they are treated and not progressing; brain imaging is not required if there is no clinical suspicion of brain metastases
• •Pregnant or lactating females are excluded
• •Uncontrolled hypertension defined as systolic blood pressure (BP) \> 140 and/or diastolic BP \> 90 initially evaluated on day of study eligibility determination (when laboratory parameters are assessed), but must be maintained on day of study initiation; (If a patient is found to have a value outside the range above, repeat BP may be assessed and if at subsequent readings x 2 (taken in clinic at least 15 minutes apart) criteria are met, the patient can then be eligible; initiation or modification of antihypertensives is allowed to achieve adequate BP for eligibility; finally, in the case that subsequent determinations are required, the BP assessment that counts towards eligibility is the reading on the day of study initiation); (note: a clinic BP reading without the patient having been at rest for 15 minutes or with the wrong cuff size can be repeated the same day for eligibility criteria to be determined
• •Active bleeding or history of bleeding from cancer related events
• •History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) or recent myocardial infarction (MI) (\< 6 months)
• •Active ulcerative colitis, Crohn's disease or Celiac disease that could interfere with the absorption of the drug
• •Current use of therapeutic anticoagulation; low dose anticoagulation for catheter prophylaxis is permitted; Lovenox is permitted for prophylaxis; (Note: patients who develop thrombosis and are placed on anticoagulation while on this trial may continue on study at the discretion of the investigator)
• •The subject has had major surgery within 28 days of Study Day 1
• •The subject has had radiation therapy within 14 days of Study Day 1
• •The subject had prior bevacizumab within 28 days of study day 1
• •No prior treatment with vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitors; prior treatment with other investigational agents is allowed
• •The subject has a medical condition, which in the opinion of the study investigator, places them at unacceptably high risk for toxicities
• •Other active malignancy for which the patient has been treated within the past one year
• •Subjects with known human immunodeficiency virus (HIV) infection are excluded
• •Subject has documented left ventricular ejection fraction (LVEF) \< 50%
• •Subject has Proteinuria \> grade 1 at baseline measured by urine dipstick (2+ or greater) and confirmed by 24 hour (hr) urine collection (\> = 1g/24hrs)