This trial is active, not recruiting.

Conditions pancreatic cancer, adenocarcinoma of the pancreas
Treatments radiation therapy, 5-fu, vorinostat
Phase phase 1/phase 2
Target HDAC
Sponsor Massachusetts General Hospital
Collaborator Dana-Farber Cancer Institute
Start date August 2009
End date August 2012
Trial size 50 participants
Trial identifier NCT00948688, 09-114


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Determine the maximally tolerated dose (MTD) and tolerability of vorinostat in combination with infusional 5-FU and radiation therapy.
time frame: 2 years
Progression free survival at 7 months from registration
time frame: 2 years

Secondary Outcomes

Determine progression free survival
time frame: 2 years
Determine toxicity profile
time frame: 2 years
Median survival, response rate and resectability rate
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Lawrence Blaszkowsky, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.