Status:
COMPLETED
3-AP and Radiation Therapy in Treating Patients With Stage III Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer AJCC v6 and v7
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of 3-AP when given together with radiation therapy in treating patients with stage III pancreatic cancer that cannot be removed by surgery...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximal tolerable dose (MTD) of 3-AP administered in combination with radiation therapy (XRT) in patients with locally advanced pancreatic carcinomas. SECONDA...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Unresectable nonmetastatic (stage III) disease
- ECOG performance status 0-2
- Life expectancy \> 12 weeks
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- AST/ALT ≤ 3 times ULN
- Creatinine normal ORcreatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during study treatment
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 3-AP (Triapine®) or other agents used in study
- No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would complicate compliance with study treatment
- No pulmonary disease (i.e., dyspnea at rest, requiring supplemental oxygen, or baseline oxygen saturation \< 92%)
- No prior chemotherapy or radiotherapy
- No concurrent antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
December 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00288093
Start Date
December 20 2006
End Date
December 28 2012
Last Update
August 18 2017
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210