Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma

Inclusion Criteria

• Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or esophageal adenocarcinoma, including GEJ adenocarcinoma which will be classified according to Siewert's classification type I, II, or III.
• Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease.
• If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (i.e. positron emission tomography [PET] scan or magnetic resonance imaging [MRI] in addition to the computed tomography [CT] scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.
• Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease. Measurable disease is defined as that which can be measured in at least one dimension as > or = 20 mm with conventional techniques, or > or = 10 mm by high resolution imaging. Disease that is identified on radiology studies, but does not meet the criteria for measurable disease, is considered non-measurable - see section 12.1.1 of protocol for further details.
• No prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration. Patients may not have received prior docetaxel or cisplatin, or bevacizumab or any other novel biologic anti-angiogenic agent.
• Age 18 years or older.
• Karnofsky performance status > or = 70% (ECOG performance status 0-1).
• Peripheral neuropathy or = 3000/mm3
• Absolute neutrophil count > or = 1500 cells/mm3
• Hemoglobin > or = 9.0 g/dl
• Platelet count > or = 100,000/mm3
• Hepatic (minimal values):
• Total bilirubin or = 1.0 at screening
• History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to the initiation of treatment.
• Serious, non-healing wound, ulcer, or bone fracture.
• Blood pressure > 150/100 mmHg
• Significant cardiac disease defined as:
• Unstable angina
• New York Heart Association (NYHA) grade II or greater
• Congestive heart failure
• History of myocardial infarction within 6 months
• Evidence of bleeding diathesis or coagulopathy.
• History of a stroke or cerebrovascular accident (CVA) within 6 months.
• Clinically significant peripheral vascular disease.
• Clinically significant hearing loss or ringing in the ears.
• Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
• Inability to comply with study and/or follow-up procedures.
• Patients with any other medical condition or reason, in the investigator's opinion, that makes the patient unstable to participate in a clinical trial.