Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

Completed · Phase 2

Conditions studied: Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

This phase II trial is studying how well triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor cells from dividing so they stop growing or die.

Key facts

Study ID

NCT00085371

Run by

National Cancer Institute (NCI)

People needed

116

Starts

2004-07-01

Last updated by the study team

2013-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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