| Exclusion Criteria: | 1) Patients may not be receiving any other investigational agents.
2) History of allergic reactions attributed to compounds of similar chemical or biologic composition to VEGF Trap, MagnevistTM , or FDG.
3) History of allergic reaction to paclitaxel or docetaxel or with products mixed in Cremephor EL or Tween 80®.
4) Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as a known bleeding disorder, coagulopathy, peptic ulcer disease, diverticulitis, or tumor involving major vessels.
5) Patients with active and/or untreated diagnosis of pulmonary embolism, deep vein thrombosis, or other thromboembolic event (i.e. any condition felt to be associated with aberrant clotting or migration of an induced clot).
6) Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of registration on this study.
7) Patients with clinically significant cardiovascular disease including: Uncontrolled hypertension (systolic >140mm Hg or diastolic >90 mm Hg); systolic blood pressure >180 mm Hg if diastolic blood pressure is less than 90 mm Hg, or diastolic blood pressure is greater than 90 mm Hg on at least 2 repeated determinations on separate days within 3 months prior to study enrollment.
8) Patients with myocardial infarction, coronary/peripheral artery bypass graft, or unstable angina within 6 months prior to registration; New York Heart Association (NYHA) Grade III or greater congestive heart failure; Serious cardiac arrhythmia requiring medication; Grade II or greater peripheral vascular disease.
9) Patients with clinically significant peripheral artery disease, e.g., those with claudication, within 6 months of registration on this study.
10) Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
11) Patients whose circumstances do not permit completion of the study or the required follow-up.
12) Patients who are ineligible to undergo an MRI scan for reasons such as claustrophobia or the presence of implanted devices or metallic foreign bodies that are not MR compatible, such as ferromagnetic implants or pacers or with a known history of allergic reaction to gadolinium contrast agents.
13) Patients who are pregnant or nursing. No fetal studies in animals or humans have been performed. The possibility of harm to a fetus is likely. VEGF Trap specifically inhibits VEGF, which is responsible for formation of new blood vessels during development and antibodies can cross the placenta. It is not known whether VEGF Trap is excreted in human milk therefore VEGF Trap should not be administered to nursing women. Women of childbearing potential must agree to use contraceptive measures during study therapy and for at least 6 months after completion of VEGF Trap therapy.
14) HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with VEGF Trap. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
15) Patients who have a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to registration.
16) Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
17) Patients who have received prior therapy with VEGF Trap. |