Pancreatic Cancer Clinical Trial
Official title:
Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Vorinostat 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. Giving
capecitabine and vorinostat together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when
given together with capecitabine and radiation therapy in treating patients with
nonmetastatic pancreatic cancer.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of vorinostat when given in combination with
capecitabine and high-dose hypofractionated radiotherapy in patients with nonmetastatic
pancreatic cancer.
Secondary
- Determine the safety and side effect profile of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
Correlative
- Compare pre- and post-treatment whole-cell HDAC-activity levels in peripheral blood
mononuclear cell samples.
- Assess chromatin structure and DNA damage in surgical tumor tissue samples.
- Assess proliferation and apoptosis by in vivo imaging.
OUTLINE: This is a dose-escalation study of vorinostat.
Patients receive oral capecitabine twice daily and undergo high-dose hypofractionated
radiotherapy once daily on days 1-5 and 8-12. Patients also receive oral vorinostat once
daily on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or
unacceptable toxicity.
Patients are evaluated for surgery within 6 weeks after completion of chemoradiotherapy.
Patients with resectable disease proceed to surgery. Patients with unresectable disease may
receive oral vorinostat once daily and oral capecitabine twice daily on days 1-14. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative laboratory studies. Patients also
undergo diffusion-weighted MRI for analysis of in vivo tumor cellularity.
After completion of study therapy, patients are followed up periodically for 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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