Gastric Cancer Clinical Trial
Official title:
Phase II Trial of Cisplatin and Irinotecan in Patients With Advanced Esophageal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients with locally advanced or metastatic esophageal or gastric cancer.
OBJECTIVES: I. Evaluate the response rate of combined cisplatin and irinotecan in patients
with metastatic or locally advanced (inoperable or recurrent) esophageal or gastric cancer.
II. Evaluate the toxic effects both qualitatively and quantitatively of cisplatin and
irinotecan in these patients. III. Estimate the disease free and overall survival of these
patients. IV. Assess whether the response proportion differs between squamous cell and
adenocarcinoma of the esophagus. V. Evaluate quality of life issues using the Memorial
Symptom Assessment Scale, the FACT-G questionnaire, and the dysphagia scale.
OUTLINE: Patients receive cisplatin and irinotecan on days 1, 8, 15, and 22 for 4 weeks,
followed by a 2 week rest period. Each treatment course lasts 6 weeks. Patients receive at
least 3 courses of therapy if the treatment is well tolerated and no disease progression is
documented. Patients attaining a complete response receive additional courses of therapy at
the discretion of the investigator. Tumor status is reassessed at 6 weeks and every 12 weeks
thereafter. Patients are followed until death.
PROJECTED ACCRUAL: A total of 28-50 patients will be accrued within 12-18 months. Accrual
for adenocarcinoma of the esophagus is complete.
;
Primary Purpose: Treatment
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