Clinical trial: Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus (NCT00005607)

Eligibility criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent adenocarcinoma of
        the stomach or gastroesophageal junction Bidimensionally measurable or evaluable disease
        Mediastinal or hilar lymph nodes assessed by CT or MRI scan must be at least 2 cm in
        diameter to be considered measurable Must not be curable with a combination of chemotherapy
        and radiotherapy No brain metastases No osseous metastasis as only site of disease

        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
        least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
        100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper
        limit of normal No known Gilbert's syndrome Renal: Creatinine no greater than 1.5 mg/dL
        Calcium no greater than 12 mg/dL No symptomatic hypercalcemia under treatment Other: Not
        pregnant or nursing Negative pregnancy test Fertile patients must use effective
        contraception No history of seizures No serious concurrent infections or nonmalignant
        medical illnesses that are uncontrolled or whose control may be jeopardized by study
        complications No psychiatric disorders that would preclude study compliance No other active
        malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of
        the cervix No uncontrolled diabetes mellitus (i.e., random blood sugar less than 250 mg)

        PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease
        No concurrent immunotherapy Chemotherapy: See Disease Characteristics No prior chemotherapy
        for metastatic disease No prior radiosensitizing chemotherapy in metastatic setting At
        least 6 months since prior adjuvant therapy No other concurrent chemotherapy Endocrine
        therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since
        prior radiotherapy and recovered No prior radiotherapy to major bone marrow containing
        areas (e.g., pelvis, lumbar spine) No prior radiotherapy to only evaluable lesion No
        concurrent radiotherapy Surgery: At least 1 week since minor surgery and 3 weeks since
        major surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other
        antiepileptic prophylaxis No concurrent prochlorperazine on day of irinotecan
        administration No other concurrent medications except for analgesics, chronic treatments
        for concurrent medical conditions, or agents required for life threatening medical problems
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