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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00983268
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2009
Status verified
Jun 2015
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm

Primary Outcome Measure

Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy [ Time Frame: Two weeks after completing radiotherapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-

Find similar trials in Nashville, TN

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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