Esophageal Cancer Clinical Trial
Official title:
Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin 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 combining irinotecan and cisplatin in
treating patients who have locally advanced unresectable or metastatic cancer of the
esophagus that has not been previously treated.
OBJECTIVES:
- Determine the objective tumor response rate in patients with previously untreated
locally advanced unresectable or metastatic esophageal cancer treated with irinotecan
and cisplatin.
- Determine the dysphagia relief in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this
regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and
8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
;
Primary Purpose: Treatment
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