Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Vorinostat

Antimetabolites

Histone Deacetylase Inhibitors

Enzyme Inhibitors

1000 mg taken by mouth on the days of radiation only.

capecitabine

Vorinostat will be given by mouth on the day of radiation and then Monday-Friday for two weeks after radiation in these 4 possible doses:

* Vorinostat,at 100 mg
* Vorinostat,at 200 mg
* Vorinostat, at 300 mg
* Vorinostat, at 400 mg

vorinostat

High-dose hypofractionated radiotherapy consisting of 3000 cGy in 10 fractions, Monday-Friday for 2 weeks.

Radiotherapy

Patients will be assessed for resectability within six weeks of the end of chemoradiation, if resectable, surgery will be performed.

Surgery to remove tumor

Emily Chan, M.D, Ph.D.

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving capecitabine and vorinostat together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with capecitabine and radiation therapy in treating patients with nonmetastatic pancreatic cancer.

OBJECTIVES:

Primary

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

Secondary

* Determine the safety and side effect profile of this regimen in these patients.
* Determine the response rate in patients treated with this regimen.

Correlative

* 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.

Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer

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

National Cancer Institute (NCI)

National Comprehensive Cancer Network

Vanderbilt-Ingram Cancer Center

Assistant Professor of Medicine; Medical Oncologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer	NCT00983268	Pancreatic Canc... Periampullary A...	capecitabine vorinostat Radiotherapy Surgery to remo...	18 Years -	Vanderbilt-Ingram Cancer Center
Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer	NCT00983268	Pancreatic Canc... Periampullary A...	capecitabine vorinostat Radiotherapy Surgery to remo...	18 Years -	Vanderbilt-Ingram Cancer Center
Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer	NCT00983268	Pancreatic Canc... Periampullary A...	capecitabine vorinostat Radiotherapy Surgery to remo...	18 Years -	Vanderbilt-Ingram Cancer Center

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