Status:
COMPLETED
Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 use...
Detailed Description
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-li...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00085371
Start Date
July 1 2004
Last Update
October 8 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905