Clinical trial: Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer (NCT00450203)

Eligibility criteria:
This is a combined eligibility criteria for both bevacizumab comparison and the lapatinib
        feasibility study. Please note the bevacizumab comparison closed to recruitment on 28th
        March 2014.

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastric or type I, II or III gastroesophageal junction
             adenocarcinoma or lower oesophageal

        Gastric and Type III junctional tumours should be Stage Ib (T1 N1, T2a/b N0), II, III or
        stage IV (T4 N1 or N2) with no evidence of distant metastases (M0)

        Lower oesophageal and Type I and II junctional tumours should be Stage II to Stage IVa (T1
        N1, T2 N1, T3 N0-1, but not T2N0). T4 (N0 or N1) tumours are also eligible providing that
        they involve only the crura OR invade only the mediastinal pleura. Patients with nodal
        disease affecting the origin of the left gastric and splenic artery or coeliac axis (staged
        as M1a) are also eligible.

          -  Resectable disease

          -  Previously untreated disease

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0 or 1

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (can be post transfusion)

          -  WBC ≥ 3,000/mm^3

          -  Glomerular filtration rate ≥ 60 mL/min

          -  Proteinuria ≤ 1 g by 24-hour urine collection

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT and AST ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 3 times ULN (in the absence of liver metastases)

          -  INR ≤ 1.5

          -  PTT ≤ 1.5 times ULN

          -  FEV_1 ≥ 1.5 L

          -  Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiogram

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must be fit enough to receive protocol treatment

          -  No other malignancies within the past 5 years except for curatively treated basal cell
             carcinoma of the skin and/or in situ carcinoma of the cervix

          -  No prior or concurrent significant medical conditions, including any of the following:

               -  Cerebrovascular disease (including transient ischemic attack and stroke) within
                  the past year

               -  Cardiovascular disease, including the following:

                    -  Myocardial infarction within the past year

                    -  Uncontrolled hypertension while receiving chronic medication

                    -  Unstable angina

                    -  New York Heart Association class II-IV congestive heart failure

                    -  Serious cardiac arrhythmia requiring medication

               -  Major trauma within the past 28 days

               -  Serious nonhealing wound, ulcer, or bone fracture

               -  Evidence of bleeding diathesis or coagulopathy

               -  Recent history of any active gastrointestinal inflammatory condition (e.g.,
                  peptic ulcer disease, diverticulitis, or inflammatory bowel disease)

                    -  If patients have a known diagnosis of any of the above, evidence of disease
                       control is required by negative endoscopy within the past 28 days

          -  No severe tinnitus

          -  No lack of physical integrity of the upper gastrointestinal tract, malabsorption
             syndrome, or inability to take oral medication

          -  No known peripheral neuropathy ≥ 1 (absence of deep tendon reflexes as the sole
             neurological abnormality does not render the patient ineligible)

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No history of interstitial lung disease or radiological evidence of lung fibrosis

          -  No known allergy to any of the following:

               -  Chinese hamster ovary cell proteins

               -  Other recombinant human or humanized antibodies

               -  Any excipients of bevacizumab formulation or platinum compounds

               -  Any other components of the study drugs

        Due to an increase in perforations associated with self-expandable metal stents in patients
        with colorectal cancer receiving bevacizumab, patients with an oesophageal or gastric stent
        (metal or biodegradable) in situ are ineligible for the study.

        PRIOR CONCURRENT THERAPY:

          -  No prior anthracycline

          -  More than 28 days since prior major surgery or open biopsy

          -  More than 10 days since prior thrombolytic therapy

          -  No concurrent thrombolytic therapy

          -  No concurrent dipyridamole

          -  No concurrent capecitabine or sorivudine (or sorivudine analogues [e.g., brivudine])

          -  No chronic, daily high-dose acetylsalicylic acid (> 325 mg/day) or nonsteroidal
             anti-inflammatory drugs

          -  No chronic corticosteroids (≥ 10 mg/day methylprednisolone equivalent)

               -  Inhaled steroids allowed

          -  No other concurrent cytotoxic agents

          -  No other concurrent investigational drugs

          -  No concurrent radiotherapy

          -  Low molecular weight heparin allowed

          -  More than 7 days since prior CYP3A4 inhibitor therapy

          -  More than 14 days since prior CYP3A4 inducer therapy

          -  More than 6 months since prior amiodarone therapy

          -  More than 14 days since prior St John's Wort, modafinil, ginkgo biloba, kava, grape
             seed, valerian, ginseng, echinacea and evening primrose oil
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.


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? 1