Clinical trial: Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer (NCT00217581)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 120 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment