Clinical trial NCT00673673 (phase 2, status: completed)
Conditions: gastroesophageal cancer, gastric cancer
ICD codes: K22.6, K21.9, K21.00, K21.01, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: folfox, bevacizumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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).