VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Inclusion Criteria

• •histologically/cytologically confirmed metastatic colorectal metastatic cancer
• •measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter) as\>20mm with conventional techniques or as \>10mm with spiral CT scan
• •\>=4 weeks from major surgery
• •at least 1prior line of systemic therapy for metastatic disease. Prior treatment with anti-epidermal growth factor receptor inhibitors is allowed. Last dose \>=4 weeks prior to randomization
• •Two cohorts: 1) bevacizumab naïveand; 2) bevacizumab treated
• •May have received prior thymidylate synthetase inhibitor concurrently with radiation as "radiation sensitizer". Last dose \>=4 weeks prior to randomization
• •Prior radiation treatment \>=4 weeks prior to randomization
• •Age\>=18 years
• •Life expectancy \>=3 months
• •ECOG\<=2 (Karnofsky=60%)
• •leukocytes \>3.0x10\^9/L
• •absolute neutrophil count \>1.5 x 10\^9/L
• •platelets\>75x10\^9/L
• •INR \<1.5 unless on warfarin
• •total bilirubin within 1.5xULN
• •AST/ALT≤2.5 X institution ULN
• •creatinine≤1.5xULN OR creatinine clearance \>60mL/min/1.73m2 for patients with creatinine levels above1.5x institution limits
• •Urinalysis negative for protein OR 24h urine for protein \<500 mg
• •full-dose anticoagulants with PT INR \>1.5 eligible provided that: a) patient is therapeutic on stable dose of warfarin or low molecular weight heparin; b) patients on warfarin, the upper target for INR is \<=3; c) no active bleeding/pathological condition carrying high bleeding risk
• •Eligibility of patients receiving medications known to affect activity/PK of VEGF Trap will be determined by PI
• •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after completion of VEGF Trap therapy
• •Ability to understand/willingness to sign written informed consent