Know Cancer

forgot password

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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer, Adenocarcinoma of the Pancreas

Thank you

Trial Information

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

- 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.

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximally tolerated dose (MTD) and tolerability of vorinostat in combination with infusional 5-FU and radiation therapy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lawrence Blaszkowsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

August 2013

Related Keywords:

  • Pancreatic Cancer
  • Adenocarcinoma of the Pancreas
  • Zolinza
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617