Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
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|ClinicalTrials.gov Identifier: NCT00053222|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : September 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: arsenic trioxide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Arsenic Trioxide In Patients With Adenocarcinoma Of The Pancreas Refractory To Gemcitabine|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||July 2007|
Experimental: Arm A
Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)
|Drug: arsenic trioxide|
- Objective response [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053222
|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|