PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
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 PNU-93914 in treating patients who have locally advanced or metastatic cancer of the esophagus.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||December 2000|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David H. Ilson, MD, PhD||Memorial Sloan-Kettering Cancer Center|