Vorinostat in Combination With Radiation Therapy and Infusional Fluorouracil (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.
Adenocarcinoma of the Pancreas
Radiation: Radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1/2 Study of Vorinostat in Combination With Radiation Therapy and Infusional 5-FU in Patients With Locally Advanced Adenocarcinoma of the Pancreas|
- Determine the maximally tolerated dose (MTD) and tolerability of vorinostat in combination with infusional 5-FU and radiation therapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Progression free survival at 7 months from registration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine toxicity profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Median survival, response rate and resectability rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Radiation: Radiation therapy
- 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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lawrence Blaszkowsky, MD||Massachusetts General Hospital|