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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Pancrelipase

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