Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00003326
- Lead Sponsor
- Theradex
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus.
- Detailed Description
OBJECTIVES: I. Determine the objective response rate of paclitaxel administered as a weekly one hour infusion in patients with metastatic, locally recurrent, or unresectable squamous cell carcinoma and adenocarcinoma of the esophagus. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life of these patients.
OUTLINE: This is an open label, multicenter study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects is observed. Patient response is assessed every 2 courses during the first year and then every 3 months in subsequent years. Quality of life is assessed prior to treatment, prior to each course for 6 courses, then every 2 courses. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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 (30)
Akron City Hospital
🇺🇸Akron, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
Northwest Medical Specialists, P.C.
🇺🇸Arlington Heights, Illinois, United States
Savannah Hematology Oncology Associates
🇺🇸Savannah, Georgia, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Missoula Medical Oncology P.C.
🇺🇸Missoula, Montana, United States
Memorial Hospital
🇺🇸Worcester, Massachusetts, United States
Lone Star Oncology
🇺🇸Austin, Texas, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Cancer Center of Southern Alabama
🇺🇸Mobile, Alabama, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Palmetto Hematology/Oncology Associates
🇺🇸Spartanburg, South Carolina, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Medicine and Dentistry of New Jersey - MOBILE
🇺🇸Newark, New Jersey, United States