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Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.

Phase 1
18 Years
Open (Enrolling)
Pancreatic Cancer, Periampullary Adenocarcinoma

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Trial Information

Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.



- Determine the maximum tolerated dose of vorinostat when given in combination with
capecitabine and high-dose hypofractionated radiotherapy in patients with nonmetastatic
pancreatic cancer.


- Determine the safety and side effect profile of this regimen in these patients.

- Determine the response rate in patients treated with this regimen.


- Compare pre- and post-treatment whole-cell HDAC-activity levels in peripheral blood
mononuclear cell samples.

- Assess chromatin structure and DNA damage in surgical tumor tissue samples.

- Assess proliferation and apoptosis by in vivo imaging.

OUTLINE: This is a dose-escalation study of vorinostat.

Patients receive oral capecitabine twice daily and undergo high-dose hypofractionated
radiotherapy once daily on days 1-5 and 8-12. Patients also receive oral vorinostat once
daily on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or
unacceptable toxicity.

Patients are evaluated for surgery within 6 weeks after completion of chemoradiotherapy.
Patients with resectable disease proceed to surgery. Patients with unresectable disease may
receive oral vorinostat once daily and oral capecitabine twice daily on days 1-14. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative laboratory studies. Patients also
undergo diffusion-weighted MRI for analysis of in vivo tumor cellularity.

After completion of study therapy, patients are followed up periodically for 5 years.

Inclusion Criteria:

- Patient must have histologically confirmed pancreatic or periampullary cancer.

- Patient must be > 18 years of age.

- Patient may be resectable, borderline resectable, or unresectable but locally
advanced as determined by radiographic examination and consultation with a surgical

- Patient must have Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

- Female patients of childbearing potential must be willing to use birth control. The 2
birth control methods can be either 2 barrier methods or a barrier method plus a
hormonal method to prevent pregnancy, used throughout the study starting with visit
1. The following are considered adequate barrier methods of contraception: diaphragm,
condom (by the partner) or sponge. Other methods of contraception such as copper
intrauterine device or spermicide may be used. Appropriate hormonal contraceptives
will include any registered and marketed contraceptive agent that contains an
estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine,
or intramuscular agents).Female patient of childbearing potential has a negative
serum pregnancy test β-hCG within 7 days prior to receiving the first dose of

- Male patients agree to use an adequate method of contraception for the duration of
the study.

- Patient has a life expectancy of at least 12 weeks

- Patient must have adequate organ function as indicated by the following laboratory

- Absolute neutrophil count (ANC) ≥1,500 /mcL

- Platelets ≥100,000 / mcL Hemoglobin ≥ 9 g/dL

- Coagulation

- Prothrombin Time or INR ≤1.5x upper limit of normal (ULN) unless receiving
therapeutic anticoagulation

- Partial thromboplastin time (PTT) ≤1.2 times the ULN unless the patient is receiving
therapeutic anticoagulation.

- K levels - Normal limits

- Mg levels - Normal limits

- Calculated creatinine *clearance ≥20 mL/min

- Serum total bilirubin ≤ 1.5 X ULN

- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN

- Alkaline Phosphatase ≤ 2.5 X ULN

* Creatinine clearance should be calculated per institutional standard.

- Patient must be capable of understanding and complying with the study protocol and
able to give informed consent.

- Measurable disease is not an eligibility requirement.

Exclusion Criteria:

- Prior chemotherapy for pancreatic or periampullary cancer.

- Prior radiation to any area within the planned radiation field. All patients with
history of prior radiation to any area must be approved by PI.

- Evidence of distant metastases on imaging.

- History of hypersensitivity to fluoropyrimidines or HDACs.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy

Outcome Time Frame:

Two weeks after completing radiotherapy

Safety Issue:


Principal Investigator

Emily Chan, M.D, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VICC GI 0934



Start Date:

October 2009

Completion Date:

March 2018

Related Keywords:

  • Pancreatic Cancer
  • Periampullary Adenocarcinoma
  • periampullary adenocarcinoma
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838