Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer
About this trial
This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas Unresectable disease Locally advanced or metastatic disease At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Measurable lesions outside prior radiotherapy field OR measurable lesions actively growing in the site of prior radiotherapy No prior chemotherapy OR previously treated with 1, and only 1, gemcitabine-containing regimen for metastatic, unresectable, or locally advanced pancreatic cancer Adjuvant therapy not considered prior chemotherapy if all treatment was completed > 6 months before tumor recurrence No known brain metastases Performance status - ECOG 0-2 At least 6 weeks Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 75,000/mm^3 AST =< 3 times upper limit of normal (ULN) Bilirubin =< 1.5 times ULN Creatinine =< 1.5 times ULN Creatinine clearance > 60 mL/min No uncontrolled congestive heart failure No unstable angina pectoris No cardiac arrhythmia No pulmonary disease requiring oxygen Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin or ancestry) No active or ongoing infection No hypersensitivity or severe allergic reaction to 3-AP (Triapine®) or related compounds No concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No other concurrent antineoplastic therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational therapy for the malignancy
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (triapene)
Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.