A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

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