A Phase II 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 Response Evaluation Criteria in Solid
Tumors (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 liver function defined as:

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x the
institutional upper limit of normal (ULN) or ≤5.0 x the institutional ULN in
patients with liver metastases.

- Total bilirubin within normal limits (WNL) (or ≤1.5 x the institutional ULN in
patients with liver metastases; or total bilirubin ≤3.0 x ULN with direct
bilirubin within normal limits in patients with well documented Gilbert
Syndrome).

- Adequate renal function defined as:

• Serum creatinine ≤1.5 mg/dL OR calculated 24-hour creatinine clearance ≥60 mL/min.

- 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.

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.

- 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.

- Serious cardiac arrhythmia requiring medication. Patients with chronic,
rate-controlled atrial fibrillation are eligible. History of stroke or transient
ischemic attack ≤6 months prior to beginning treatment.

- Any prior history of hypertensive crisis or hypertensive encephalopathy.

- Any known positive test for human immunodeficiency virus, hepatitis C virus or acute
or chronic hepatitis B infection.

- 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).