A Phase II Multicenter Study of the Efficacy and Safety Study of PNU-93914 (Liposome Encapsulated Paclitaxel) in Patients With Advanced Esophageal Cancer Previously Exposed to Chemotherapy

OBJECTIVES: I. Determine the antitumor activity and duration of activity of PNU-93914 in patients with locally advanced or metastatic esophageal carcinoma. II. Determine the objective tumor response rate and tumor response duration in patients treated with this drug. III. Determine the survival of patients treated with this drug. IV. Determine the safety profile of this drug in these patients. V. Determine the effect of this drug on the quality of life of these patients. VI. Determine the time to tumor response, time to tumor progression, and time to treatment failure in patients treated with this drug. VII. Evaluate the change in dysphagia score in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive PNU-93914 IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course, and then at the final study visit. Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.