Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Locally advanced or metastatic disease Unidimensionally measurable disease At least 1 lesion that is at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan Must have progressed after chemotherapy with a gemcitabine-containing regimen No known brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 5 times upper limit of normal Renal Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular QTc less than 500 msec at baseline by EKG No New York Heart Association class III or IV heart failure No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reactions attributed to compounds of similar chemical or biological composition to arsenic trioxide No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent colony-stimulating factors during the first course of the study Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior arsenic trioxide No other concurrent chemotherapy No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy No concurrent hormonal therapy Radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent therapeutic radiotherapy Surgery At least 4 weeks since major surgery Other No other concurrent investigational or commercial anticancer agents or therapies No other concurrent investigational agents No concurrent antiretroviral therapy in HIV-positive patients No concurrent medications for other comorbid conditions that are known to prolong the QT interval
Sites / Locations
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Evanston Northwestern Health Care - Evanston Hospital
- Ingalls Memorial Hospital
- LaGrange Memorial Hospital
- Loyola University Medical Center
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Arms of the Study
Arm 1
Experimental
Arm A
Arsenic trioxide (0.3 mg/kg/day iv for 5 days every 28 days)