A Phase I Study of Triapine® in Combination With Radiation Therapy in Locally Advanced Pancreas Cancer
18 Years
N/A
Both
Adenocarcinoma of the Pancreas, Stage III Pancreatic Cancer
Trial Information
A Phase I Study of Triapine® in Combination With Radiation Therapy in Locally Advanced Pancreas Cancer
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.
SECONDARY OBJECTIVES:
I. To document the therapeutic response of this combination in patients with locally
advanced pancreatic carcinomas.
II. To establish radiographic correlates using secretin stimulated magnetic resonance
cholangiopancreatography (MRCP) and dynamic contrast enhanced magnetic resonance imaging
(MRI).
III. To measure deoxycytidine triphosphate (dCTP) levels in peripheral blood mononuclear
cells (PBMCs)before and after treatment at specified times and try to correlate findings to
activity and toxicity of triapine.
OUTLINE: This is a dose-escalation study of 3-AP (Triapine®). Patients undergo radiotherapy
once daily, 5 days a week, for approximately 5½ weeks (a total of 28 fractions).
Patients also receive 3-AP (Triapine®) IV over 2 hours 3 days a week every other week for 5½
weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 3-AP (Triapine®) until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients
are treated at the MTD. After completion of study treatment, patients are followed monthly
for 1 year.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD as assessed by the number of patients with dose-limiting toxicity (DLT)
Outcome Description:
MTD will be the dose at which 1 or fewer patients (less than or equal to 1/6) experiences a DLT during the treatment cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will be defined as greater than or equal to Grade 3 non-hematologic or greater than or equal to Grade 4 hematologic adverse event with the following exceptions: greater than or equal to Grade 3 nausea and greater than or equal to Grade 3 vomiting that improves with antiemetic therapy greater than or equal to Grade 3 diarrhea that improves with Lomotil.
Outcome Time Frame:
Observed clinically for 3-4 hours after each 3-AP infusion during the first week of treatment
Safety Issue:
Yes
Principal Investigator
Tanios Bekaii-Saab
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2009-00120
NCT ID:
NCT00288093
Start Date:
December 2006
Completion Date:
Related Keywords:
- Adenocarcinoma of the Pancreas
- Stage III Pancreatic Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Ohio State University Medical Center | Columbus, Ohio 43210 |
