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

Inclusion Criteria

• Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
• Patients must have measurable disease per RECIST Version 1.1.
• No previous systemic therapy for metastatic colorectal cancer. Previous radiosensitizing chemotherapy is allowed, if completed at least 4 weeks prior to Cycle 1 Day 1 of study treatment, and previous neoadjuvant and/or adjuvant chemotherapy is allowed, if completed at least 6 months prior to diagnosis of metastatic disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
• Life expectancy >=12 weeks.
• Adequate hematologic, renal and hepatic function
• Patients who are on coumadin should have an INR value within the therapeutic range (i.e., 2 to 3 x ULN). Patients who are on stable, chronic doses of coumadin are eligible.
• Male patients willing to use adequate contraceptive measures. Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test performed within 72 hours prior to start of treatment.
• Willingness and ability to comply with the trial and follow-up procedures.
• Ability to understand the investigative nature of this trial and give written informed consent.

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 =2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate 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) =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.