A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab For Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Bevacizumab may make tumor cells more sensitive to both chemotherapy and radiation therapy. Giving chemotherapy and bevacizumab before and after radiation therapy may kill more tumor cells. This phase II trial is studying how well giving capecitabine and bevacizumab together with radiation therapy followed by gemcitabine and bevacizumab works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
详细描述
PRIMARY OBJECTIVES:
I. Compare 1-year overall survival of patients with unresectable locally advanced pancreatic cancer treated with capecitabine, bevacizumab, and radiotherapy followed by maintenance therapy comprising gemcitabine and bevacizumab to a historical control.
SECONDARY OBJECTIVES:
I. Determine the frequency of serious unacceptable adverse events in patients treated with this regimen.
II. Determine the response rate in patients treated with this regimen. III. Determine the progression-free survival of 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
- •Histologically confirmed adenocarcinoma of the pancreas
- •Locally advanced disease
- •Unresectable disease
- •All malignant disease must be encompassable within a single irradiation field
- •Radiographically assessable disease
- •Patients with biliary or gastroduodenal obstruction are eligible provided drainage or surgical bypass was performed prior to initiation of study treatment
- •No evidence of gastric outlet obstruction
- •No evidence of duodenal invasion on CT scan
- •No evidence of metastatic disease in the major viscera
- •No peritoneal seeding or ascites
- •Performance status - Zubrod 0-1
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No evidence of bleeding diathesis
- •ALT < 3 times upper limit of normal
- •Bilirubin < 2.0 mg/dL
- •INR ≤ 1.5
- •No evidence of coagulopathy
- •Creatinine clearance > 50 mL/min
- •Urine protein < 1,000 mg by 24-hour urine collection (for patients with proteinuria ≥ 1+ by dipstick or urinalysis OR urine protein:creatinine ratio ≥ 1.0)
- •No myocardial infarction within the past 6 months
- •No unstable angina within the past 6 months
- •No arterial thromboembolic events within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Clinically significant peripheral artery disease
- •No unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [i.e., atrial fibrillation or paroxysmal supraventricular tachycardia])
- •Patients with an atrial arrhythmia are eligible provided the condition is well controlled on stable medication
- •No New York Heart Association class II-IV congestive heart failure
- •No history of arteriovenous malformation
- •No history of aneurysm
- •No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg with medication)
- •No other clinically significant cardiac disease
- •No significant infection
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •Not pregnant
- •No nursing during and for ≥ 3-4 months after completion of study treatment
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 3-4 months after completion of study treatment
- •No history of gastrointestinal fistula or perforation
- •No other malignancy within the past two years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
- •No significant traumatic injury within the past 4 weeks
- •No serious nonhealing wound or ulcer
- •No current healing fracture
- •No known or suspected dihydropyrimidine dehydrogenase deficiency
- •No other medical condition that would preclude study participation
- •No concurrent interleukin-11
- •No prior chemotherapy for pancreatic cancer
- •More than 2 years since prior chemotherapy for another malignancy
- •No prior radiotherapy to the planned irradiation field
- 另有 15 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: capecitabine (Drug)
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: radiation therapy (Radiation)
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: therapeutic conventional surgery (Procedure)
Treatment (capecitabine, radiation, bevacizumab, gemcitabine)
Chemoradiotherapy and bevacizumab: Patients receive oral capecitabine twice daily and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Patients undergo reevaluation 3-4 weeks after completion of chemoradiotherapy and bevacizumab.
Patients with no evidence of disease progression proceed to maintenance therapy. Patients with a marked response may undergo surgery at the discretion of the attending surgeon and then proceed to maintenance therapy approximately 4-8 weeks later.
Maintenance therapy: Beginning within 4-7 weeks after completion of chemoradiotherapy and bevacizumab, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30 minutes on days 1 and 15 provided that blood counts have returned to normal. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Overall survival rate
时间窗: 1 year
Will be estimated using the Kaplan-Meier method.
次要结局
- Frequency of patients developing grade 3 or greater adverse events as defined per CTCAE version 3.0(Up to 1 year)
- Progression-free survival(Up to 1 year)
- Response rate(Up to 1 year)