Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer

Phase 2

Completed

• Conditions: Esophageal Cancer; Gastric Cancer

• Registration Number: NCT00003055
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 combination chemotherapy in treating patients with locally advanced or metastatic esophageal or gastric cancer.

Detailed Description

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.

Study Timeline

• Study Start: 1997-06
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-04
• Study Completion: 2001-04
• Study First Submitted QC: 2004-07-29
• Study First Posted: 2004-07-30
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States