Esophageal Cancer Clinical Trial
Official title:
A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Patients With Advanced Esophageal Cancer
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.
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.
;
Primary Purpose: Treatment
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