Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
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 arsenic trioxide in treating patients who have locally advanced or metastatic pancreatic cancer that has not responded to gemcitabine.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine|
- Objective response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Study Completion Date:||July 2007|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)
|Drug: arsenic trioxide|
- 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.
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Decatur Memorial Hospital Cancer Care Institute|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Health Care - Evanston Hospital|
|Evanston, Illinois, United States, 60201-1781|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|LaGrange Memorial Hospital|
|LaGrange, Illinois, United States, 60525|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Incorporated|
|Fort Wayne, Indiana, United States, 46885-5099|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Michigan|
|Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph|
|Saint Joseph, Michigan, United States, 49085|
|Study Chair:||Hedy L. Kindler, MD||University of Chicago|