A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine
OBJECTIVES:
- Determine the objective response rate to arsenic trioxide in patients with pancreatic
cancer who have progressed after first-line treatment with a gemcitabine-containing
regimen when treated with arsenic trioxide.
- Determine the toxicity of this drug in these patients.
- Determine the duration of response, median and overall survival, and time to
progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 9-12
months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response
3 years
No
Hedy L. Kindler, MD
Study Chair
University of Chicago
United States: Federal Government
11839A
NCT00053222
February 2003
July 2007
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Evanston Northwestern Health Care - Evanston Hospital | Evanston, Illinois 60201 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
LaGrange Memorial Hospital | LaGrange, Illinois 60525 |