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Keep this study
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES:
I. Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine\^®) as first- or second-line therapy.
SECONDARY OBJECTIVES:
I. Determine the toxicity and tolerability of this drug in these patients. II. Determine the time to treatment failure in patients treated with this drug. III. Determine overall survival and disease progression in patients treated with this drug.
IV. Determine tumor response in patients treated with this drug. V. Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).
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.
Patients are followed every 3-6 months for 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
