Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
- Registration Number
- NCT00053222
- Lead Sponsor
- University of Chicago
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A arsenic trioxide Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)
- Primary Outcome Measures
Name Time Method Objective response 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
LaGrange Memorial Hospital
🇺🇸LaGrange, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States