3-AP and Radiation Therapy in Treating Patients With Stage III Pancreatic Cancer That Cannot Be Removed By Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/19/2017 |
| Start Date: | December 20, 2006 |
| End Date: | December 28, 2012 |
A Phase I Study of Triapine® in Combination With Radiation Therapy in Locally Advanced Pancreas Cancer
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.
3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP may make tumor
cells more sensitive to radiation therapy. Giving 3-AP together with radiation therapy may
kill more tumor cells.
with radiation therapy in treating patients with stage III pancreatic cancer that cannot be
removed by surgery.
3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP may make tumor
cells more sensitive to radiation therapy. Giving 3-AP together with radiation therapy may
kill more tumor cells.
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.
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
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