NCT00983268

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer
• Periampullary Adenocarcinoma

Interventions

Type	Name	Description
DRUG	capecitabine	1000 mg taken by mouth on the days of radiation only.
DRUG	vorinostat	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
RADIATION	Radiotherapy	High-dose hypofractionated radiotherapy consisting of 3000 cGy in 10 fractions, Monday-Friday for 2 weeks.
PROCEDURE	Surgery to remove tumor	Patients will be assessed for resectability within six weeks of the end of chemoradiation, if resectable, surgery will be performed.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-09-24
• Last updated: 2015-06-15

Locations

1 site across 1 country: United States