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

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Dana-Farber Cancer Institute; Merck Sharp & Dohme Corp.
• Treatments: Fluorouracil; Pancrelipase; Vorinostat

Criteria

Inclusion Criteria:

• Histologically or cytologically proven adenocarcinoma of the pancreas

• Evaluable disease

• Must have received 3-4 months of gemcitabine-based chemotherapy and have had stable disease by RECIST criteria. Regimens include:

• gemcitabine alone

• gemcitabine and erlotinib

• gemcitabine and oxaliplatin

• gemcitabine and cisplatin

• gemcitabine and capecitabine

• 18 years of age or older

• Life expectancy of greater than 4 months

• ECOG Performance Status 0-1

• Normal organ and marrow function as outlined in the protocol

• Ability to drink at least 2 liters of fluid daily

• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

• Patients must be able to swallow capsules

Exclusion Criteria:

• Chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

• Participants may not be receiving any other study agents

• Known distant metastases to any organ

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or 5-FU

• Patients taking warfarin due to potential interactions of both 5-FU and vorinostat. Low molecular weight heparin should be substituted when appropriate

• Patients who have received upper abdominal radiation therapy which fields would overlap with that determined necessary to treat the primary tumor.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or breastfeeding women

• Individuals with history of a different malignancy are ineligible unless they are deemed by the investigator to be at low risk of recurrence of that malignancy. Patients may not have a concurrent second malignancy.

• Active HIV or hepatitis

• Prior exposure to HDAC inhibitor (except valproic acid, provided there is a 30 day washout period)