NCT00361231已完成2 期
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Median Progression Free Survival
研究概览
简要总结
The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.
详细描述
- The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
- Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
- The following tests and procedures will be performed on day 1 and day 15 or each cycle: physical examination; medical history; blood work; and urine test. A PET scan will be repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
- Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
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 unresectable or metastatic biliary tract or gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside prior radiation field.
- •Zero to one prior chemotherapy for biliary tract or gallbladder cancer
- •Age > 18 years
- •ECOG performance status 0-2
- •Life expectancy > 12 weeks
- •Adequate organ and bone marrow function
排除标准
- •Chemotherapy within past 3 weeks of initiation of therapy
- •Pregnant or lactating women
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL
- •Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Uncontrolled serious medical or psychiatric illness
- •Pre-existing peripheral neuropathy of grade 2 or greater severity according to the Common Terminology Criteria of the NCI (version 3.0)
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- •Blood pressure of > 150/100 mmHg
- •Unstable angina
- •NYHA Grade II or greater congestive heart failure
- •History of myocardial infarction or stroke within 6 months
- •Clinically significant peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedure, open biopsy, or significant traumatic injury with 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1
- •Serious, non-healing wound, ulcer, or bone fracture
研究组 & 干预措施
Bevacizumab, Gemcitabine, Oxaliplatin
Experimental
- The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
- Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
- Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
干预措施: Bevacizumab (Drug)
Bevacizumab, Gemcitabine, Oxaliplatin
Experimental
- The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
- Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
- Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
干预措施: Gemcitabine (Drug)
Bevacizumab, Gemcitabine, Oxaliplatin
Experimental
- The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
- Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
- Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Median Progression Free Survival
时间窗: 2 years
To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.
次要结局
- Overall Response Rate(2 years)
研究者
Andrew X. Zhu, MD
Principal Investigator
Massachusetts General Hospital
研究点 (2)
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