NCT00948688

Vorinostat With XRT and 5-FU for Locally Advanced Adenocarcinoma of the Pancreas

Phase 1/2 Study of Vorinostat in Combination With Radiation Therapy and Infusional 5-FU in Patients With Locally Advanced Adenocarcinoma of the Pancreas

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Pancreatic Cancer
• Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Once per day, 5 days a week for 6 weeks
DRUG	5-FU	Intravenously over 24 hours, 7 days per week during each week of radiation therapy
DRUG	Vorinostat	Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-06-01
• Completion: 2013-11-01
• First posted: 2009-07-29
• Last updated: 2017-05-10
• Results posted: 2017-05-10

Locations

2 sites across 1 country: United States