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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine  Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
For Condition: stage 4A pancreatic cancer,stage 4B pancreatic cancer,adenocarcinoma of the pancreas,recurrent pancreatic cancer,stage 3 pancreatic cancer,stage 2 pancreatic cancer
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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 metastaticpancreatic cancer that has not responded to gemcitabine.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, 49085
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201-1781
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Additional Information:
Study ID Numbers: CDR0000269303; NCI-5839,UCCRC-NCI-5839
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053222
Other Stage 3 Pancreatic Cancer Studies:
1. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
2. Adjuvant Chemoradiotherapy and Interferon alfa in Treating Patients With Resected Pancreatic Cancer
3. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas
4. Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer
5. Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Indiana Clinical Trials
Other Ft. Wayne Clinical Trials
Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
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