FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
Condition: Gastroesophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: FOLFOX; bevacizumab
Intervention description: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours; bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Intervention MeSH terms: Bevacizumab; Fluorouracil
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
Healthy volunteers: No

Summary:

      This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of
      FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or
      unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to
      determine the time to progression in patients treated with FOLFOX in combination with
      bevacizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented recurrent, metastatic or unresectable
             gastroesophageal (Siewert type I, II, III) or gastric adenocarcinoma with measurable
             or assessable non-measurable disease (RECIST criteria).

          -  If recurrent or metastatic disease is not histologically confirmed, then documentation
             by a second radiographic procedure (i.e., PET 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

          -  12 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy
             or radiotherapy) for potentially resectable gastroesophageal or gastric
             adenocarcinoma.

          -  >4 weeks since major surgery.

          -  ECOG Performance Status: 0-1

          -  Life expectancy >12 weeks

          -  Laboratory parameters as follows: absolute neutrophil count ≥1,500/uL, platelet count
             ≥100,000/uL, hemoglobin ≥9 g,/dL, creatinine <1.5 X ULN or estimated GFR >30 ml's/min,
             urinalysis <2+ protein, baseline proteinuria <1000 mg/d or urine protein/creatinine
             ratio <1, bilirubin <2 X ULN, PT (INR) <1.5 if patient not on anticoagulation,
             negative pregnancy test in women of childbearing age

          -  Hypertension must be well controlled (<160/90)

          -  Paraffin block or slides must be available

          -  Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an
             in-range INR or be on a stable dose of low molecular weight heparin.

        Exclusion Criteria:

          -  prior treatment for recurrent, metastatic, or unresectable gastroesophageal or gastric
             adenocarcinoma

          -  other concurrent anticancer therapy

          -  other malignancy within past three years except basal cell carcinoma of the skin,
             cervical carcinoma in situ, or nonmetastatic prostate cancer known central nervous
             system metastases or carcinomatous meningitis.

          -  interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.

          -  > grade 2 sensory peripheral neuropathy.

          -  uncontrolled seizure disorder, active neurological disease, or known CNS disease.

          -  significant cardiac disease, including the following: unstable angina, New York Heart
             Association class II-IV congestive heart failure, myocardial infarction within six
             months prior to study enrollment.

          -  history of hypertensive crisis or hypertensive encephalopathy

          -  abdominal fistula, gastrointestinal bleeding, or intra-abdominal abscess within the 6
             months prior to study enrollment.

          -  core biopsy or other minor surgical procedure, excluding placement of a vascular
             access device, within 7 days prior to study enrollment.

          -  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.

          -  recent arterial thrombotic events including stroke or TIA within 6 months prior to
             study enrollment.

          -  serious or non-healing wound, ulcer or bone fracture.

          -  active bleeding or pathological condition that carries a high risk of bleeding (e.g.,
             tumor involving major vessels or known varices).