Phase 1/2 Study of Vorinostat in Combination With Radiation Therapy and Infusional 5-FU in Patients With Locally Advanced Adenocarcinoma of the Pancreas
- Since we are looking for the highest dose of vorinostat that can be administered safely
without severe or unmanageable side effects, not everyone who participates will receive
the same dose. The dose will depend upon the number of participants enrolled on the
study and how well they have tolerated their doses.
- 5-FU will be given intravenously over 24 hours 7 days per week during each week of
radiation therapy. In order for participants to be able to receive the 5-FU as an
outpatient, they will need to have central line catheter placed.
- Radiation therapy will be given once per day, 5 days per week, for 6 weeks.
- Vorinostat is taken orally.
- Participants will be seen once per week during the 6 weeks that they are receiving
5-FU, radiation therapy and vorinostat.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximally tolerated dose (MTD) and tolerability of vorinostat in combination with infusional 5-FU and radiation therapy.
Lawrence Blaszkowsky, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|