Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer

Exclusion Criteria

• •Patients with untreated CNS metastases.
• •Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:
• •1. Cardiovascular disease
• •1. Unstable angina
• •2. Myocardial infarction/ CABG \< 3 months prior to study initiation
• •3. Untreated coronary artery disease
• •4. NYHA class III or IV heart failure
• •2. Ongoing serious infection
• •1. Bacteremia or sepsis requiring intravenous antibiotics
• •2. HIV with AIDS defining illness
• •3. Inadequate oral nutritional intake: Requirement for daily intravenous fluids or total parenteral nutrition.
• •4. Neurological: Stroke ≤ 6 months
• •5. Psychiatric illness/social situations that would limit compliance with study requirement
• •Patients may not receive another investigational agent.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ziv-aflibercept.
• •Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
• •Major surgical procedure ≤ 4 weeks from starting therapy.
• •Grade 3-4 hemorrhage, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulits ≤ 3 months from starting therapy.
• •Patients with known DPD deficiency
• •Patients with known Gilbert's syndrome
• •Patients with ≥ 2g/24 hour urine protein. If urine protein on random UA is ≤ 300 mg/dl, a 24 hour urine protein is not required.
• •Symptomatic peripheral sensory neuropathy grade ≥ 2.
• •Other malignancy within the last 5 years from study entry, except for basal /squamous cell skin cancer, in situ cervical cancer, or non-metastatic prostate cancer.