Clinical trial: Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach (NCT00004235)

Eligibility criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the
        lower esophagus, esophagogastric junction, or gastric cardia that is considered
        unresectable and for which no curative therapy exists No other conventional forms of
        therapy available that would offer a reasonable chance of cure or significant palliation
        Gastric cardia is defined as no greater than 5 cm from the esophagogastric junction into
        the stomach Measurable disease At least 1 lesion that can be accurately measured in at
        least 1 dimension as at least 20 mm No nonmeasurable lesions only, including: Bone lesions
        Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease
        Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging
        techniques Cystic lesions No known untreated or treated symptomatic CNS metastases

        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
        least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
        at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no
        greater than ULN (less than 2.5 times ULN if alkaline phosphatase no greater than ULN)
        Alkaline phosphatase no greater than ULN (4 times ULN if AST no greater than ULN) Renal:
        Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association
        class III or IV heart disease Neurologic: No grade 2 or greater peripheral neuropathy of
        any etiology No uncontrolled seizure disorder Other: Not pregnant or nursing Negative
        pregnancy test Fertile patients must use effective contraception Ability to complete
        questionnaires alone or with assistance No uncontrolled infection No chronic debilitating
        disease No other prior malignancy within the past 5 years except adequately treated basal
        cell or squamous cell skin cancer or other noninvasive carcinoma

        PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for
        recurrent or metastatic disease No concurrent biologic therapy No concurrent filgrastim
        (G-CSF) as primary prophylaxis Chemotherapy: Prior adjuvant chemotherapy after complete
        resection of original tumor allowed Prior neoadjuvant chemotherapy allowed No prior
        chemotherapy for recurrent or metastatic disease No other concurrent chemotherapy Endocrine
        therapy: Not specified Radiotherapy: Prior adjuvant radiotherapy after complete resection
        of original tumor allowed Prior neoadjuvant radiotherapy allowed At least 4 weeks since
        prior radiotherapy No prior radiotherapy for recurrent or metastatic disease No prior
        radiotherapy to more than 25% of bone marrow No concurrent radiotherapy except to CNS
        Surgery: See Disease Characteristics Prior surgical resection of primary tumor allowed At
        least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)
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