Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer
Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.
5 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pancreatic-cancer
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 24, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJune 15, 2015
June 1, 2015
3.3 years
September 23, 2009
June 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy
Two weeks after completing radiotherapy
Secondary Outcomes (3)
Toxicity as assessed by NCI CTCAE v3.0
Six weeks after completing chemo-radiation therpay
Tumor response as assessed by RECIST criteria
Six weeks after completing chemo-radiation therpay
Biological effect
Six weeks after completing chemo-radiation therapy
Study Arms (1)
Treatment Arm
EXPERIMENTALInterventions
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
High-dose hypofractionated radiotherapy consisting of 3000 cGy in 10 fractions, Monday-Friday for 2 weeks.
Patients will be assessed for resectability within six weeks of the end of chemoradiation, if resectable, surgery will be performed.
Eligibility Criteria
You may qualify if:
- 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 oncologist.
- 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 vorinostat.
- 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 values:
- 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
- +7 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- National Comprehensive Cancer Networkcollaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Chan, M.D, Ph.D.
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine; Medical Oncologist
Study Record Dates
First Submitted
September 23, 2009
First Posted
September 24, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 15, 2015
Record last verified: 2015-06