Clinical trial: Perioperative Panitumumab and Epirubicin, Oxaliplatin and Xeloda (EOX) in Patients With Gastroesophageal Adenocarcinoma (NCT00667420)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed diagnosis of
             adenocarcinoma of the stomach, gastroesophageal junction, or lower third of the
             esophagus, AJCC stage II-IIIB (gastric) or IIA-IVA (esophageal). M1a disease will be
             included, but not T4 lesions.

          -  No prior radiation or chemotherapy including anti-EGFR or vascular endothelial growth
             factor (VEGF) antibody or tyrosine kinase inhibitor treatments.

          -  All patients must have staging endoscopic ultrasound (EUS) prior to enrollment.

          -  Men or Women >18 years of Age

          -  ECOG performance status <2 (Karnofsky >60%, see Appendix A).

          -  Cardiac ejection fraction >45% by echocardiogram or MUGA scan.

          -  Must be able to either swallow pills or have gastrostomy tube in place for
             administration of enteral medications.

          -  Patients must have normal organ, metabolic and marrow function as defined below:

               -  Hematologic function, as follows:

                    -  Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

                    -  Platelet count ≥ 100 x 109/L

                    -  Hemoglobin ≥ 9.0 g/dL

               -  Renal function, as follows:

                    -  Creatinine < or = 1.5 mg/dL x ULN

        Hepatic function, as follows:

          -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)< or = 3 x ULN

          -  Total bilirubin < 1.5 x ULN

        Metabolic function, as follows:

          -  Magnesium ≥ lower limit of normal

          -  Calcium < or = lower limit of normal -Human IgG is known to cross the placental
             barrier; therefore, Panitumumab may be transmitted from the mother to the developing
             fetus. In women of childbearing potential, appropriate contraceptive measures must be
             used during treatment with panitumumab and for 6 months following the last dose of
             panitumumab. If panitumumab is used during pregnancy or if the patient becomes
             pregnant while receiving this drug, she should be apprised of the potential risk for
             loss of the pregnancy or potential hazard to the fetus.

        3.1.10 Ability to understand and the willingness to sign and date a written IEC/IRB
        approved informed consent form.

        Exclusion Criteria:

          -  Evidence of distant metastatic disease.

          -  T4 tumor on initial staging studies.

          -  History of another primary cancer, except:

          -  Curatively treated in situ cervical cancer

          -  Curatively resected non-melanoma skin cancer

          -  Other primary solid tumor curatively treated with no known active disease present and
             no treatment administered for ³ 5 years prior to enrollment

          -  Relative or absolute contraindications to surgery which in the opinion of the
             investigator make the patient a poor candidate for surgical resection.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to panitumumab or other agents used in study.

          -  Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate,
             cyclosporine).

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any
             evidence of interstitial lung disease on baseline chest CT scan.

          -  History of any medical or psychiatric condition or laboratory abnormality that in the
             opinion of the investigator may increase the risks associated with the study
             participation or investigational product(s) administration or may interfere with the
             interpretation of the results.

          -  Subject unwilling or unable to comply with study requirements.

          -  Women who test positive for serum or urine pregnancy test < 72 hours before
             randomization or are breast feeding.

          -  Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus,
             acute or chronic active hepatitis B infection.

          -  Major surgery with 28 days or minor surgery within 14 days of study enrollment.

          -  Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not
             surgically sterilized, or not abstinent) not consenting to use adequate contraception
             (per institutional standard of care) during the course of the study and after the last
             investigational product(s) administration (24 weeks for women, 4 weeks for men).

          -  Subjects with > grade 1 neuropathy at baseline.

          -  Contraindication to port-a-cath placement.
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