VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Inclusion Criteria:

• Bilirubin =< 1.5 times upper limit of normal (ULN)
• AST/ALT =< 2.5 times ULN
• Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min
• Proteinuria =< 1+ by dipstick OR urine protein < 500 mg by 24-hour urine analysis
• No serious or nonhealing wound, ulcer, or bone fracture
• No abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within the past 28 days
• At least 4 weeks since prior major surgical procedure or open biopsy
• Histologically or cytologically confirmed colorectal cancer
• No significant traumatic injury within the past 28 days
• Recovered from prior therapy
• Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan
• No prior surgery, radiation therapy, or radiofrequency ablation to the measurable lesion
• Has received >= 1 prior systemic chemotherapy for metastatic disease AND has documented radiological or clinical progression after the most recent therapy
• No CNS disease, including primary brain tumor or brain metastasis
• Life expectancy >= 3 months
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• No clinically significant cardiovascular disease, including, but not limited to, any of the following: Peripheral vascular disease within the past 6 months (i.e., limiting activities of daily living or the presence of resting pain), Deep vein thrombosis, pulmonary embolism, or other thromboembolic event within the past 6 months, Coronary artery bypass graft within the past 6 months, OR;
• OR; Unstable angina pectoris or myocardial infarction within the past 6 months, New York Heart Association class III or IV congestive heart failure, Serious cardiac arrhythmia requiring medication, Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg (if diastolic BP < 90 mm Hg) within the past 3 months
• No evidence of bleeding diathesis or coagulopathy
• No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection, Psychiatric illness or social situation that would limit compliance with study requirements
• No active bleeding or pathological condition that carries a high risk of bleeding (e.g., evidence of tumor invading major vessels by CT scan or known varices)
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No history of allergic reactions to compounds of similar chemical or biologic composition to VEGF Trap or other agents used in this study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for >= 6 months after completion of study treatment
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), prior thymidylate synthetase inhibitor (e.g., fluorouracil or capecitabine) allowed as a radiosensitizer
• At least 4 weeks since prior radiation therapy of local disease, disease progression must be documented afterwards
• At least 4 weeks since other prior anticancer agents
• At least 4 weeks since prior thrombolytic agents
• At least 7 days since prior core biopsy
• No prior antiangiogenic therapy (e.g., vascular endothelial growth factor tyrosine kinase inhibitor) other than bevacizumab
• Prior anti-epidermal growth factor receptor inhibitors allowed
• No other concurrent investigational agents
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent major surgery
• Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin) allowed provided dose is stable
• WBC >= 3,000/mm^3
• Absolute neutrophil count >= 1,500/mm^3
• Platelet count >= 75,000/mm^3
• INR =< 1.5 (=< 3 if on full-dose warfarin)
• Metastatic disease
• Concurrent antihypertensive medications allowed, unless dose and/or quantity has been increased within the past 2 weeks