Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma

Inclusion Criteria

• •All patients must have microscopically confirmed adenocarcinoma of the stomach or GE junction. Tumors involving the GE junction must have the bulk of their disease in the stomach; tumors of the distal esophagus that extend less than 2cm into the stomach are ineligible for this study.
• •All patients must be considered candidates for surgical resection.
• •Patients must have FDG-avid malignancies.
• •FDG avid tumors are defined as primary tumors with an increased tracer uptake in the region of the tumor that has an SUV \> or = to 3.5 or a tumor:liver ratio \> or = to 1.5, and felt to be "probably" or "definitely malignant" (i.e. likelihood score of 3 or 4) by the reference nuclear medicine physician.
• •All patients must have localized cancer potentially curable by surgery. The tumor stage should be T any N+ M0 or T3-T4a N any M0(AJCC 7th Edition), by staging that includes a CT scan and either laparoscopy or endoscopic ultrasound. Patients with T1-2 N0M0 or patients with distant metastatic disease (i.e. M1) are ineligible. Any sites of suspected M1 disease by these criteria must be proven to be M0 prior to entrance into the neoadjuvant study.
• •Patients may not have received prior chemotherapy or radiation for this disease.
• •The patient is at least 18 years of age.
• •If female and of child bearing potential, the patient has a negative serum pregnancy test within 14 days of starting therapy, and, if male or female and of child bearing potential, currently uses (and agree to continue to use throughout the study) an acceptable method of birth control (IUD, oral contraceptive, or barrier device). They should agree to continue to use these for three months after the study is completed. The patient also agrees to refrain from nursing during the duration of the study and for at least two months after the study is completed. Pregnant or lactating females are not included because the anti-proliferative effects of bevacizumab may be harmful to the fetus or developing infant.
• •Karnofsky performance status \> or = to 70%.
• •The patient has adequate hematopoietic function, defined as having a total neutrophil count (ANC) ≥ or = to 1500/mm3, a platelet count ≥ or = 100,000/mm3. The patient has adequate renal and hepatic function, defined as having a serum creatinine ≤ or = to 2.5 mg/dl, urinalysis demonstrating \< 2+ proteinuria and/or a urine protein/creatinine (UPC) ratio \< 1.0. LFTs include a total serum bilirubin ≤ than or = to 2 x ULN, serum AST (SGOT)/ALT (SGPT) and ALK PHOS \< than or = to 2.5 ULN.
• •The patient has a PT (INR) \< than or = to 1.5 and an PTT \< than or = to 3 seconds above the upper limits of normal (i.e. at MSKCC PTT \< than or = to 37.7 sec) if the patient is not on anticoagulation.
• •If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment
• •1. If using warfarin, the subject must have an in-range INR (usually between 2 and 3) and on a stable dose of warfarin.
• •2. The subject must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
• •Ability to understand informed consent and signing of written informed consent document prior to the initiation of treatment.