Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma

Inclusion Criteria

Subjects must be treated at Stanford University Medical Center for the entire length of study participation.

• Patients with histologically or cytologically confirmed adenocarcinoma of the GEJ or stomach.
• Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion. If unresectable, patients must show evidence of disease progression prior to enrollment.
• Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
• Prior carboplatin as neoadjuvant or adjuvant therapy will be allowed if >= 6 months from the time of study entry.
• If patients use aspirin (>325mg/day) or NSAIDS at the time of enrollment, they must have a 10 day washout period prior to beginning protocol treatment.
• Low molecular weight heparin (or its equivalent, excluding warfarin) will be allowed for treatment of venous thromboembolic events if patients have no evidence of bleeding on full-dose anticoagulation.
• Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (see Section 11.2.3) within 4 weeks prior to entry of study
• Patients must have ECOG performance status of 0-1
• Patients must be >= 18 years of age
• Laboratory values = 1.5 x 109/L (>= 1500/mm3)
• Platelets (PLT) >= 100 x 109/L (>= 100,000/mm3)
• Hemoglobin (Hgb) >= 9 g/dL
• Serum creatinine = 12 weeks
• Inclusion and exclusion criteria for DCE-MRI and DWI imaging will be determined by CT scan as part of routine post-chemotherapy imaging. Subjects will be eligible if one liver metastasis is greater than 1 cm in size. Participation in the DCE-MRI and DWI correlate is not required for eligibility.
• Ability to give written informed consent according to local guidelines

Exclusion Criteria

• Disease-Specific Exclusions
• Prior chemotherapy for metastatic disease
• Prior full field radiotherapy = CTCAE grade 2 dyspnea)
• Any of the following concurrent severe and/or uncontrolled medical conditions within 24 weeks of enrollment which could compromise participation in the study:
• Unstable angina pectoris
• Symptomatic congestive heart failure
• Myocardial infarction 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix A)
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment
• History of stroke or transient ischemic attack within 6 months prior to study enrollment
• Known CNS disease, brain metastases.
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
• Serious, non-healing wound, ulcer, or bone fracture
• Urine protein >= 2+ on urinalysis dipstick and >= 1.0 gram on 24-hour urine collection
• Known hypersensitivity to any component of bevacizumab
• History of hemoptysis (bright red blood of ½ te