Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 7:26 AM
Study NCT ID:
NCT00983268
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VICC-GI-0934 | None | None | View | |
| IRB# 090791 | None | None | View | |
| NCCN-M02 | None | None | View |