A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma

Inclusion 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