• Progression-free survival (PFS) as measured by RECIST criteria at 6 months [ Designated as safety issue: No ]
  

• Response rate [ Designated as safety issue: No ]
  
• Median PFS [ Designated as safety issue: No ]
  
• Overall survival and survival at 1 year [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the efficacy of combination chemotherapy comprising modified docetaxel, cisplatin, fluorouracil, and leucovorin calcium with bevacizumab, as measured by 6-month progression-free survival (PFS), in patients with locally recurrent, unresectable, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.

Secondary

• Determine the safety of this regimen in these patients.
• Determine other measures of efficacy of this regimen, including response rate, median PFS, and overall and 1-year survival, in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive bevacizumab IV over 30 minutes, docetaxel IV over 1 hour, and leucovorin calcium IV over 30 minutes on days 1, 15, and 29; fluorouracil IV continuously on days 1-3, 15-17, and 29-31; and cisplatin IV over 30 minutes on days 3, 17, and 31. Courses repeat every 6 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed gastric or esophageal adenocarcinoma

  • Gastroesophageal junction adenocarcinoma classified according to Siewert's class type I-III allowed

• Locally recurrent, metastatic, or unresectable disease

  • If recurrent or metastatic disease is not histologically confirmed, then documentation by a second radiographic procedure (i.e., positron emission tomography scan or MRI in addition to CT scan) is required
  • If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation is required

• Measurable or nonmeasurable disease that can be radiographically evaluated

  • Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by high-resolution imaging
  • Nonmeasurable disease is defined as disease that can be identified on radiology studies, but does not meet the criteria for measurable disease
• No brain or CNS metastases, including leptomeningeal disease

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Bilirubin normal
• Creatinine ≤ 1.5 mg/dL

• Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

  • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST and ALT normal
• Urinalysis < 2+ proteinuria
• Urine protein/urine creatinine ratio < 1.0
• PT (INR) ≤ 1.5 and PTT ≤ 3 seconds above ULN (if patient not on anticoagulation)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• No peripheral neuropathy > grade 1
• No other neoplastic disease within the past 3 years, except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
• No significant traumatic injury within the past 28 days
• No abdominal fistula, gastrointestinal bleeding, or intraabdominal abscess within the past 6 months
• No serious, nonhealing wound, ulcer, or bone fracture
• Blood pressure ≤ 150/100 mm Hg

• No significant cardiac disease, including any of the following:

  • Unstable angina
  • New York Heart Association class II-IV heart disease
  • Congestive heart failure
  • Myocardial infarction within the past 6 months
• No stroke or cerebrovascular accident within the past 6 months
• No clinically significant peripheral vascular disease
• No clinically significant hearing loss or ringing in the ears
• No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• No other medical condition or reason that, in the opinion of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

• Recovered from prior therapy
• No prior chemotherapy for metastatic or unresectable disease
• No prior docetaxel, cisplatin, bevacizumab, or any other novel biologic antiangiogenic agent
• More than 6 months since prior fluorouracil
• More than 6 months since prior adjuvant therapy (including chemotherapy and/or chemoradiotherapy)
• More than 7 days since prior minor surgery, including fine-needle aspiration, core biopsy, laparoscopy, or mediport placement
• More than 28 days since prior major surgery or open biopsy
• No concurrent major surgery
• No other concurrent chemotherapy or anticancer therapy
• No concurrent immunotherapy or radiotherapy

• Concurrent full-dose anticoagulants allowed if the following criteria are met:

  • In-range INR (usually 2-3) on a stable dose of warfarin or low molecular weight heparin
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)