Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

Official Title: Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer

Study ID: NCT00030862

Conditions

Esophageal Cancer

Interventions

cisplatin

irinotecan hydrochloride

Study Description

Brief Summary: 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.

Detailed Description: 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.