Clinical trial: Genotype Guided Chemotherapy in Gastric Cancer Patients (NCT02204306)

Eligibility criteria:
Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed metastatic adenocarcinoma
             of the stomach.

          2. Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >20
             mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for
             the evaluation of measurable disease.

          3. No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is
             permitted if the disease free interval has been longer than 12 months.

          4. Age between 18 and 70 years. Because no dosing or adverse event data are currently
             available on the use of these regimens in patients <18 years of age, children are
             excluded from this study.

          5. Life expectancy of greater than 3 months.

          6. ECOG performance status < 2 (Karnofsky >60%; see Appendix A).

          7. Patients must have normal organ and marrow function as defined below:

               -  Leukocytes >3,000/microliter

               -  Absolute neutrophil count >1,500/microliter

               -  Platelets >100,000/microliter

               -  Total bilirubin < 1.5 x ULN

               -  AST(SGOT)/ALT(SGPT) <2.5 x ULN if not liver metastases < 5 x ULN if known liver
                  metastases

               -  Creatinine clearance <1.5 x ULN

          8. Not pregnant. Not breast feeding. If the patient or partner is of childbearing
             potential, the couple will use adequate birth control in accordance with local IRB
             policies:

             For woman of childbearing potential:

             Patient must have negative blood pregnancy test. If sexually active, woman must either
             be post-menopausal (over age 50 and have not had a menstrual period for one year or
             more, or blood FSH level in the post-menopausal range) OR agree to use appropriate
             contraceptive measures for the duration of the study and for 21 days after stopping
             study treatment. The only birth control methods for women that are acceptable for this
             study are: (1) surgical sterilization (previous removal of the uterus or both ovaries
             or a tubal ligation) OR (2) an intrauterine device (IUD), (3) double barrier methods,
             (4) oral contraceptives.

             For men:

             Medically acceptable contraceptives include: (1) surgical sterilization, or (2) a
             condom used with a spermicide. If the female partner becomes pregnant while patient is
             on treatment or within 21 days after stopping treatment, the study physician must be
             informed.

          9. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Patients may not be receiving any other chemotherapy agents.

          2. Patients with known active brain metastases. Patients with treated brain metastases
             are permitted if stable off steroids for at least 30 days. A screening head CT/MRI is
             not required in asymptomatic patients for this protocol.

          3. History of allergic reactions to 5-FU, oxaliplatin, docetaxel, or cisplatin.

          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          5. Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with the chemotherapies.
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 70 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