Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer
OBJECTIVES:
- Determine the time to progression and time to treatment failure in patients with
unresectable locally advanced or metastatic epithelial carcinoma of the pancreas
treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
- Determine the best overall response rate and duration of response in patients treated
with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit and safety of this drug in these patients.
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours
on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Time to progression
No
John S. MacDonald, MD
Study Chair
Beth Israel Comprehensive Cancer Center - West Side Campus
United States: Federal Government
CDR0000433513
NCT00111904
May 2005
Name | Location |
---|---|
St. Vincent's Comprehensive Cancer Center - Manhattan | New York, New York 10011 |
Midwest Cancer Research Group, Incorporated | Skokie, Illinois 60077 |
Louisiana Oncology Associates - Lafayette | Lafayette, Louisiana 70506 |
Southwest Regional Cancer Center - Central | Austin, Texas 78705 |
Florida Cancer Specialists - Bonita Springs | Bonita Springs, Florida 34135 |