Phase I/II Trial of Vorinostat and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
The Study Drugs:
Vorinostat is designed to interfere with the growth of cancer cells.
Study Drug Dose Level:
If you are found to be eligible to take part in the study, you will begin receiving
vorinostat. The dose you receive will be based on how many participants have been enrolled
before you, and on the safety data available. The first group of 3 enrolled participants
will be given low doses of vorinostat. If no intolerable side effects occur, the next group
of 3 will be enrolled at a higher dose level. The study doctor will tell you what dose you
will be receiving and how it compares to the doses other participants have received. Up to
3 dose levels will be tested.
Study Drug Administration:
On each day that you receive radiation, you will take vorinostat (as a capsule taken by
mouth) in the morning with food.
You will receive radiation once a day on Monday through Friday, except for holidays. This
schedule will be continued for 5 1/2 weeks or 28 doses total. Each radiation treatment will
usually last about 10-15 minutes.
After completing radiation therapy, you will come back for a follow-up visit about 6-12
Length of Study:
You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the
disease gets worse or intolerable side effects occur.
This is an investigational study. Vorinostat is FDA approved and commercially available.
The use of vorinostat for pancreatic cancer and in combination with radiation is
investigational. At this time, this combination is being used in research only.
Up to 37 patients will take part in the study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation
MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).
Toxicity assessment at 6 weeks following chemoradiation (6 weeks)
Sunil Krishnan, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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