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Phase 1/2 Study of Vorinostat in Combination With Radiation Therapy and Infusional 5-FU in Patients With Locally Advanced Adenocarcinoma of the Pancreas
The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC) inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. In this research study vorinostat will be given along with radiation therapy and the drug 5-FU. This is the first research study in which vorinostat will be given along with radiation therapy and 5-FU. The purpose of this research study is to find the highest dose of vorinostat that can be given safely along with radiation therapy and 5-FU. The investigators will also begin to get information about whether vorinostat combined with radiation and 5-FU may help to treat pancreatic cancer.
* 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
August 1, 2009
Primary Completion Date
June 1, 2012
Completion Date
November 1, 2013
Last Updated
May 10, 2017
10
ACTUAL participants
Radiation therapy
RADIATION
5-FU
DRUG
Vorinostat
DRUG
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT04550494
NCT05053971
Data Source & Attribution
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