3-AP and Radiation Therapy in Treating Patients With Stage III Pancreatic Cancer That Cannot Be Removed By Surgery
Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v6 and v7
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas Unresectable nonmetastatic (stage III) disease ECOG performance status 0-2 Life expectancy > 12 weeks WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Total bilirubin ≤ 2 times upper limit of normal (ULN) AST/ALT ≤ 3 times ULN Creatinine normal ORcreatinine clearance ≥ 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception prior to and during study treatment No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 3-AP (Triapine®) or other agents used in study No known glucose-6-phosphate dehydrogenase (G6PD) deficiency No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would complicate compliance with study treatment No pulmonary disease (i.e., dyspnea at rest, requiring supplemental oxygen, or baseline oxygen saturation < 92%) No prior chemotherapy or radiotherapy No concurrent antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer agents or therapies
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (triapine, radiation therapy)
Patients undergo radiotherapy once daily, 5 days a week, for approximately 5.5 weeks (a total of 28 fractions). Patients also receive 3-AP (Triapine) IV over 2 hours 3 days a week every other week for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 3-AP (Triapine) until the maximum tolerated dose (MTD) is determined.