Clinical trialPhase 1 / Phase 2Terminated

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

NCT00948688 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Stopped earlyFunding was withdrawn after only 10 participants were enrolled (Business decision)
Phase: Phase 1 / Phase 2
Status: Terminated
Study type: Interventional
Start: August 2009
Expected end: November 2013
Enrollment: 10 participants
Sites: 2
Primary outcomes: Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy.; Progression Free Survival (PFS) at 7 Months From Registration
Sponsor: Other
Results posted: 2017-05-10
Last update: 10 May 2017

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

* 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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy. [6 weeks]. Number, milligrams per day. Vorinostat, 5-FU, Radiation Therapy (n=10): NA [Criteria for Maximum Tolerated Dose (MTD) were not met before premature closure of the study and therefore a MTD was not determined.].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) at 7 Months From Registration [7 months]. Median, months (95% Confidence Interval). Vorinostat, 5-FU, Radiation Therapy (n=10): NA (1.74342 to NA) [The estimated survival probability never reached 50% during 7 months of follow-up, so the median and 95% CI could not be calculated.].