Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00030862
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States