NCT00983268已完成1 期
Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment Arm
Experimental
干预措施: capecitabine (Drug)
Treatment Arm
Experimental
干预措施: vorinostat (Drug)
Treatment Arm
Experimental
干预措施: Radiotherapy (Radiation)
Treatment Arm
Experimental
干预措施: Surgery to remove tumor (Procedure)
结局指标
主要结局
Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy
时间窗: Two weeks after completing radiotherapy
次要结局
- 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)
研究者
Emily Chan, MD, PhD
Assistant Professor of Medicine; Medical Oncologist
Vanderbilt-Ingram Cancer Center
研究点 (1)
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