Clinical trial: Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer (NCT01359397)

Eligibility criteria:
Inclusion Criteria:

          1. Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction
             with inoperable locally advanced or recurrent and/or metastatic disease not amenable
             to curative therapy.

          2. Measurable disease, according to the Response Evaluation Criteria in Solid Tumours
             (RECIST), assessed using imaging techniques (CT or MRI)

          3. ECOG Performance status 0, 1 or 2 (see Appendix 2)

          4. Life expectancy of at least 3 months

          5. Male or female age ≥ 18 years.

          6. Signed informed consent.

          7. Assessment of HER2 status (primary tumour or metastasis) by the central laboratory
             prior to initiation of study treatment (see section 9.1)

          8. Able to swallow and retain oral medication.

          9. LVEF ≥ 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac
             ultrasound.

        Exclusion Criteria:

        Any of the following will exclude the patient from the study:

          1. Previous chemotherapy for advanced/metastatic disease (prior peri-operative
             chemotherapy is allowed if at least 6 months has elapsed between completion of this
             therapy and enrolment into the study).

          2. Previous radiotherapy on the abdomen.

          3. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
             or basal cell carcinoma.

          4. Patients with active (significant or uncontrolled) gastrointestinal bleeding.

          5. Residual relevant toxicity resulting from previous therapy (with the exception of
             alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE.

          6. Creatinin clearance <50 mL/min.

          7. Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L.

          8. Serum bilirubin >1.5 × upper limit of normal (ULN); or, AST or ALT >2.5 × ULN (or >5 ×
             ULN in patients with liver metastases); or, alkaline phosphatase >2.5 × ULN (or >5 ×
             ULN in patients with liver metastases, or >10 × ULN in patients with bone but no liver
             metastases); or, albumin <25 g/L.

          9. Known dihydropyrimidine dehydrogenase (DPD) deficiency.

         10. History of documented congestive heart failure; angina pectoris requiring medication;
             evidence of transmural myocardial infarction on ECG; poorly controlled hypertension
             (systolic BP >180 mmHg or diastolic BP >100 mmHg); clinically significant valvular
             heart disease; or high risk uncontrollable arrhythmias.

         11. Patients with dyspnoea at rest due to complications of advanced malignancy or other
             disease, or who require supportive oxygen therapy.

         12. Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and
             short courses of oral steroids for anti-emesis or as an appetite stimulant are
             allowed).

         13. Major surgery within 4 weeks of start of study treatment; serious or not healing
             wound.

         14. Known hypersensitivity to any of the study drugs, Chinese hamster ovary cell products
             or other murine or human recombinant antibodies.

         15. History or clinical evidence of brain metastases.

         16. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly
             controlled diabetes.

         17. Positive serum pregnancy test in women of childbearing potential.

         18. Subjects with reproductive potential not willing to use an effective method of
             contraception.

         19. Any investigational drug treatment within 4 weeks of start of study treatment.

         20. Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if
             palliative radiotherapy given to bone metastastic site peripherally and patient
             recovered from any acute toxicity)

         21. Arterial thrombosis; cerebrovascular accident within 6 months prior to study
             enrolment.

         22. Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs.

         23. Continuous use of immunosuppressive agents (for the use of corticosteroids see also
             #12).
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? Entailment