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)
Cancer Center of Southern Alabama
🇺🇸Mobile, Alabama, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Savannah Hematology Oncology Associates
🇺🇸Savannah, Georgia, United States
Northwest Medical Specialists, P.C.
🇺🇸Arlington Heights, Illinois, United States
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Scroll for more (20 remaining)Cancer Center of Southern Alabama🇺🇸Mobile, Alabama, United States