Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Time to Tumor Progression
研究概览
简要总结
The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
详细描述
- Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days.
- Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle.
- Bevacizumab will be given intravenously on days 1 and 15 (once every 2 weeks) of the treatment cycle.
- Erlotinib will be taken orally every day of the treatment cycle.
- Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment. During all of the following cycles, they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle.
- Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study.
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
- •Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas
- •ECOG Performance Status 0-2
- •18 years of age or older
- •Radiographically measurable disease
- •Expected survival of at least 4 months
- •Creatinine of </= 2.0
- •Adequate hepatic function
- •Adequate hematopoietic function
- •Use of effective means of contraception in subjects of child-bearing potential
排除标准
- •Warfarin anticoagulation
- •Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor
- •Coexistent malignant disease
- •Current or recent (within 4 weeks) participation in a clinical trial
- •Pregnancy
- •Documented invasion of adjacent organs or major blood vessels
- •Blood pressure of > 150/100mmHg
- •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 of coagulopathy
- •Presence of CNS or brain metastases
- •Major surgical procedure, open biopsy, or significant traumatic event within 28 days
- •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
- •Serious non-healing wound, ulcer or bone fracture
研究组 & 干预措施
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
干预措施: Bevacizumab (Drug)
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
干预措施: Erlotinib (Drug)
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Time to Tumor Progression
时间窗: all patients will be followed for a minimum of 4 months
Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. 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.
次要结局
- Response Rate(after at least one 28-day cycle of treatment)
- Toxicity Profile(during and after first 28-day cycle of treatment)
- Overall Survival(5 years)
研究者
Lawrence S. Blaszkowsky, MD
Assistant Physician
Massachusetts General Hospital