Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Intervention: Bevacizumab; Docetaxel; Oxaliplatin
Intervention description: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.; Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;; Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
Intervention MeSH terms: Bevacizumab; Docetaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent gastric cancer; stage III gastric cancer; stage IV gastric cancer; recurrent esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; adenocarcinoma of the stomach

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
      tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as
      oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving bevacizumab together with
      oxaliplatin and docetaxel may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with
      oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or
      metastatic stomach or gastroesophageal junction cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastric or gastroesophageal junction adenocarcinoma

               -  Locally advanced unresectable or metastatic disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10mm by spiral CT scan

               -  Bone metastases, ascites, or pleural effusions are not considered measurable
                  disease

               -  Evaluable disease must be present outside previously irradiated field

          -  No CNS or brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  SWOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 mg/dL

          -  No evidence of bleeding diathesis or coagulopathy

        Hepatic

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Bilirubin ≤ ULN

          -  INR < 1.5

        Renal

          -  Creatinine < 2.0 mg/dL

          -  Urine protein:creatinine ratio < 1.0

        Cardiovascular

          -  No history of deep venous thrombosis requiring anticoagulation

          -  No active angina

          -  No myocardial infarction within the past year

          -  No cerebrovascular accident within the past year

          -  No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or
             diastolic BP > 100 mm Hg) despite medical management

        Other

          -  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 history of allergy to any of the study drugs or drugs formulated with polysorbate
             80

          -  No known HIV infection

          -  No active peptic ulcer disease

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No unresolved bacterial infection requiring antibiotics

          -  No other active malignancy within the past 3 years except for cancers that have been
             treated with a curative intent

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after
             completion of non-taxane adjuvant chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since radiotherapy

        Surgery

          -  At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter
             placement)

          -  No concurrent surgery

        Other

          -  At least 4 weeks since prior and no concurrent participation in another experimental
             drug trial

          -  No concurrent full-dose anticoagulation

          -  No concurrent experimental drugs