A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

Exclusion Criteria

• •History or known presence of central nervous system (CNS) metastases.
• •Patients who have had a major surgical procedure (not including mediastinoscopy), or significant traumatic injury \<=4 weeks prior to beginning treatment.
• •Women who are pregnant or lactating. All females of child-bearing potential must have negative serum or urine pregnancy tests within 72 hours prior to study treatment (see Appendix D)
• •History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, bevacizumab, oxaliplatin, or axitinib), or known dipyrimidine dehydrogenase deficiency.
• •Patients with proteinuria at screening as demonstrated by:
• •* Urine dipstick for proteinuria \>=2+ (patients discovered to have \>=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate \<=1 g of protein/24 hours to be eligible)
• •Patients with a serious non healing wound, active ulcer, or untreated bone fracture.
• •Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
• •Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) \<=1 month prior to study enrollment.
• •Patients requiring concomitant treatment with potent CYP3A4 or CYP1A2 inducers and CYP3A4 inhibitors.
• •History of myocardial infarction or unstable angina \<=6 months prior to beginning treatment.
• •Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to Day 1 of study treatment.
• •New York Heart Association Grade II or greater congestive heart failure.
• •Serious cardiac arrhythmia requiring medication. Patients with chronic, rate-controlled atrial fibrillation are eligible.
• •Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) \<=6 months prior to Day 1 of treatment.
• •History of stroke or transient ischemic attack \<=6 months prior to beginning treatment.
• •Any prior history of hypertensive crisis or hypertensive encephalopathy.
• •History of abdominal fistula or gastrointestinal perforation \<=6 months prior to Day 1 of beginning treatment.
• •Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Any known positive test for human immunodeficiency virus, hepatitis C virus or acute or chronic hepatitis B infection.
• •Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• •Use of any non-approved or investigational agent \<=28 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
• •Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a disease free survival \>=5 years.
• •Infection requiring IV antibiotics.
• •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g. active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection).
• •Inability to swallow whole tablets.
• •Patients with \> Grade 2 peripheral neuropathy.