RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced cancer of the stomach.
OBJECTIVES: I. Evaluate the response rate, survival, and toxicity of previously untreated patients with locally advanced or metastatic gastric cancer who are treated with irinotecan (CPT-11). OUTLINE: This is a nonrandomized study. Patients receive irinotecan (CPT-11) by IV over 90 minutes every 3 weeks. Dosage modifications are made based on toxicity. Retreatment may be delayed another 3 weeks (for a total of 6 weeks) to allow for recovery from toxic effects. Patient is taken off study if they do not recover from toxic effects, unless cause is documented to be unrelated to CPT-11. Patients with stable disease or partial response continue on treatment until disease progression or intolerable toxicity. Patients with complete response continue on treatment for another 2 courses and then are observed. Patients are followed every 3 months for 3 years or until disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
response rate
Time frame: Up to 3 years
survival
Time frame: Up to 3 years
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...and 9 more locations