Clinical trial: Irinotecan in Treating Patients With Advanced Cancer of the Stomach (NCT00003137)

Eligibility criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the stomach or
        gastroesophageal junction beyond hope of surgical cure and not considered a candidate for
        potentially curative chemotherapy/radiation therapy Measurable or evaluable disease Tumor
        must be accessible for biopsy No known central nervous system metastases or carcinomatous
        meningitis

        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
        least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
        at least 150,000/mm3 Hemoglobin at least 9.0 mg/dL (transfusion allowed) Hepatic: Bilirubin
        no greater than upper limit of normal (ULN), regardless of liver involvement secondary to
        tumor AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN
        Cardiovascular: No unstable angina No uncontrolled high blood pressure No active congestive
        heart failure No myocardial infarction in the last 6 months No serious uncontrolled cardiac
        arrhythmia No New York Heart Association Class III or IV heart disease Pulmonary: No
        interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung No
        pleural effusion or ascites, which cause respiratory compromise (at least Grade 2 dyspnea)
        Other: No active or uncontrolled infection No prior malignancy, except for adequately
        treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas,
        or other cancer from which the patient has been disease free for at least 5 years Not
        pregnant or nursing Adequate contraception required of all fertile patients

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
        chemotherapy for gastric or gastroesophageal junction cancer No prior irinotecan (CPT-11)
        or other camptothecin Endocrine therapy: Not specified Radiotherapy: No prior abdominal or
        pelvic radiotherapy No prior radiotherapy to greater than 25% of bone marrow No prior
        radiotherapy to measurable or evaluable indicator lesions At least 4 weeks since major
        radiotherapy (chest radiotherapy) Surgery: At least 3 weeks since major surgery and
        recovered At least 2 weeks since minor surgery and recovered Other: No other concurrent
        investigational 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