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Phase I/II Trial of Vorinostat and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Phase I/II Trial of Vorinostat and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer

The Study Drugs:

Vorinostat is designed to interfere with the growth of cancer cells.

Study Drug Dose Level:

If you are found to be eligible to take part in the study, you will begin receiving
vorinostat. The dose you receive will be based on how many participants have been enrolled
before you, and on the safety data available. The first group of 3 enrolled participants
will be given low doses of vorinostat. If no intolerable side effects occur, the next group
of 3 will be enrolled at a higher dose level. The study doctor will tell you what dose you
will be receiving and how it compares to the doses other participants have received. Up to
3 dose levels will be tested.

Study Drug Administration:

On each day that you receive radiation, you will take vorinostat (as a capsule taken by
mouth) in the morning with food.


You will receive radiation once a day on Monday through Friday, except for holidays. This
schedule will be continued for 5 1/2 weeks or 28 doses total. Each radiation treatment will
usually last about 10-15 minutes.

Surgical Evaluation:

After completing radiation therapy, you will come back for a follow-up visit about 6-12
weeks later.

Length of Study:

You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the
disease gets worse or intolerable side effects occur.

This is an investigational study. Vorinostat is FDA approved and commercially available.
The use of vorinostat for pancreatic cancer and in combination with radiation is
investigational. At this time, this combination is being used in research only.

Up to 37 patients will take part in the study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

2. Patients must be >/= 18 years of age. There will be no upper age restriction.

3. Cytologic or histologic proof of adenocarcinoma of the pancreas. Patients can have
tumor originating in any part of the pancreas. Islet cell tumors are not eligible.
Only patients with non- metastatic, unresectable disease (American Joint Committee on
Cancer (AJCC) 2002 stage T4 NX M0) are eligible. Patients who cannot undergo
resection because of underlying medical problems are also eligible. Patients with
regional nodal disease are eligible.

4. All patients must be staged with a physical exam, chest x-ray/CXR, and
contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT
criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric
(SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or
SM/ portal vein confluence. If a tumor does not meet this definition and is found to
be unresectable at surgical exploration, then that tumor is considered unresectable.

5. Patients may have received prior chemotherapy but not prior radiation therapy to the
upper abdomen.

6. Bone marrow function: absolute neutrophil count (ANC) >1,500/ul. Platelets

7. Hepatic function: Total bilirubin less than 1.5mg/dL. If the patient required an
endobiliary stent and/or external biliary drain, the bilirubin level must have
declined on consecutive measurements indicating adequate biliary decompression;
alanine aminotransferase (ALT)
8. Renal function: Blood urea nitrogen (BUN)
9. Patients must be willing to sign informed consent indicating that they are aware of
the investigational nature of the study, and are aware that participation is

Exclusion Criteria:

1. Prior abdominal radiotherapy.

2. Participation in any other experimental drug study in the 30 days preceding
initiation of treatment on the current study.

3. Prior treatment with HDAC inhibitors (except valproic acid with a 30-day washout

4. Prior history of cancer within the last five years except for basal cell carcinoma of
the skin or carcinoma in situ of the cervix. Patients with previous malignancies but
without evidence of disease for 5 years will be allowed to enter the trial.

5. Pregnant or lactating women. Women of childbearing potential with either a positive
or no pregnancy test at baseline. Women / men of childbearing potential not using a
reliable contraceptive method (oral contraceptive, other hormonal contraceptive,
intrauterine device, diaphragm or condom). (Postmenopausal women must have been
amenorrheic for at least 12 months to be considered of non-childbearing potential).
Patients must agree to continue contraception for 30 days from the date of the last
study drug administration.

6. Serious, uncontrolled, concurrent infection(s) requiring intravenous (IV) antibiotics
or nonmalignant medical illnesses that are uncontrolled or whose control may be
jeopardized by the complications of this therapy.

7. Current treatment of active hepatitis virus or HIV infection with interferon,
ribavirin, telbivudine, entecavir, lamivudine, adefovir, efavirenz, zidovudine,
tenofovir, emtricitabine, or ritonavir.

8. Psychiatric disorders rendering patients incapable of complying with the requirements
of the protocol.

9. Inability to comply with study and/or follow-up procedures.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation

Outcome Description:

MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).

Outcome Time Frame:

Toxicity assessment at 6 weeks following chemoradiation (6 weeks)

Safety Issue:


Principal Investigator

Sunil Krishnan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

October 2010

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • Pancreatic Cancer
  • Locally Advanced Pancreatic Cancer
  • LAPC
  • Non-Metastatic
  • Unresectable
  • Vorinostat
  • XRT
  • RT
  • Radiation Therapy
  • SAHA
  • Suberoylanilide Hydroxamic Acid
  • MSK-390
  • Pancreatic Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030