Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients
研究概览
简要总结
The main purpose of this study is to test the safety and effectiveness of oxaliplatin, bevacizumab, and capecitabine given in combination with radiation therapy to see what effects (good or bad) they have on patients with biliary tract and gallbladder cancer.
详细描述
There are two phases of study treatment. The first phase is for all patients and will last about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week during weeks 1, 2, 4, and 5 on days 1, 8, 22, and 29; bevacizumab will be given intravenously once every 2 weeks during weeks 1, 3, and 5 on days 1, 15, and 29; capecitabine will be administered orally for 14 consecutive days (days 1-14), then a week of no capecitabine, followed by another 14 days of capecitabine (days 22-35).
Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments.
During this first phase of the study the following tests will be performed weekly: physical exam, vital signs, medical history, blood tests and urine tests.
After the first phase is finished patients will wait 4 weeks then have a CT scan, MRCP, blood tests and a physical exam to evaluate the status of the disease.
Phase two of the study is broken up into two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease.
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
- •Histologically confirmed locally advanced unresectable biliary tract or gallbladder adenocarcinoma
- •Patients with resected biliary tract or gallbladder adenocarcinoma who have residual tumor left will also be eligible.
- •> 4 weeks since time of major surgery
- •> 2 weeks since time of minor surgery
- •> 4 weeks since time of major radiotherapy for other malignancy
- •> 4 weeks since participation in any investigational drug study
- •> 1 year since treatment for other carcinomas, except cured non-melanoma skin and treated in-situ cervical cancer
- •18 years of age or older
- •ECOG performance status of 0-2
- •Life expectancy > 12 weeks
- •Absolute neutrophil count (ANC) > 1,500/mm3
- •Hemoglobin > 9.0 gm/dl
- •Platelets > 100,000/mm3
- •SGOT < 5 x upper limits of normal (ULN)
- •Total bilirubin < 2.5 mg/dl
- •Creatinine clearance > 50 ml/min
排除标准
- •Prior chemotherapy or radiation therapy for biliary tract or gallbladder cancer
- •Peripheral neuropathy of grade 2 or greater
- •Unstable angina
- •Symptomatic congestive heart failure
- •Myocardial infarction < 12 months prior to registration
- •New York Heart Association classification III or IV
- •Active or uncontrolled infection
- •Known existing uncontrolled coagulopathy
- •Malabsorption syndrome or lack of integrity of the upper gastrointestinal (GI) tract
- •Prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Known brain metastases or carcinomatous meningitis
- •Pregnant or lactating women
- •Serious, non-healing wound, ulcer, or bone fracture
- •Evidence of bleeding diathesis or coagulopathy
研究组 & 干预措施
Capecitabine, Oxaliplatin, Bevacizumab
There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.
干预措施: Capecitabine (Drug)
Capecitabine, Oxaliplatin, Bevacizumab
There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.
干预措施: Oxaliplatin (Drug)
Capecitabine, Oxaliplatin, Bevacizumab
There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.
干预措施: Bevacizumab (Drug)
Capecitabine, Oxaliplatin, Bevacizumab
There are two phases of study treatment. Phase I includes all patients and will last 6 weeks. During this phase, oxaliplatin will be given intravenously (IV) on days 1, 8, 22, and 29; bevacizumab will be given IV on days 1, 15, and 29; capecitabine will be administered orally on days 1-14 and 22-35. Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total of 28 treatments. Phase II has two groups: 1) patients who had tumors removed prior to entering study and 2) patients who entered the study with advanced disease. Patients who had their tumors removed prior to entering the study will be treated with the above 6-week regimen twice for a total of 12 weeks of treatment. Patients who were unresectable prior to entering the study but then were deemed resectable after treatment on trial will undergo resection. Following surgical recovery (8-10 weeks) they will be treated again with the above 6-week regimen twice for a total of 12 weeks of treatment.
干预措施: Radiation therapy (Procedure)
结局指标
主要结局
To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients
时间窗: 3 years
次要结局
- To evaluate the safety of the combination capecitabine, oxaliplatin, bevacizumab in patients with biliary tract and gallbladder cancer(3 years)
研究者
Andrew X. Zhu, MD
Principal Investigator
Massachusetts General Hospital