Clinical trial: Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer (NCT00514020)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
             stomach or gastroesophageal junction

               -  Metastatic disease

          -  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

          -  No known active brain metastases

               -  Patients with treated brain metastases are eligible if stable off steroids for at
                  least 30 days

        PATIENT CHARACTERISTICS:

          -  ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)

          -  Life expectancy ≥ 3 months

          -  WBC ≥ 3,000/μL

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelets ≥ 100,000/μL

          -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

          -  AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)

          -  Creatinine clearance ≤ 1.5 x ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 21 days after
             completion of study treatment

          -  No history of allergic reactions to fluorouracil or oxaliplatin

          -  No concurrent uncontrolled illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for metastatic disease

               -  Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has
                  been longer than 6 months

          -  No other concurrent chemotherapy

          -  No concurrent combination anti-retroviral therapy for HIV-positive patients

          -  No concurrent routine prophylaxis with filgrastim (G-CSF)

          -  No other concurrent antineoplastic agents, including chemotherapy, radiation therapy,
             or biologic agents
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