Status:
COMPLETED
Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Conditions:
Pancreatic Cancer
Periampullary Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 sto...
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 pancre...
Eligibility Criteria
Inclusion
- 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
- Calculated creatinine \*clearance ≥20 mL/min
- Serum total bilirubin ≤ 1.5 X ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
- Alkaline Phosphatase ≤ 2.5 X ULN
- \* Creatinine clearance should be calculated per institutional standard.
- Patient must be capable of understanding and complying with the study protocol and able to give informed consent.
- Measurable disease is not an eligibility requirement.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00983268
Start Date
October 1 2009
End Date
February 1 2013
Last Update
June 15 2015
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838