A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Patients with Resection
研究概览
简要总结
Primary Objective:
- To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.
Secondary Objectives:
- To assess disease free survival and overall survival
- To assess margin resection rate (R0 vs. R1) in these patients
- To assess patterns of failure
详细描述
Gemcitabine is designed to disrupt the growth of the cancer cells, which causes the cancer cells to start to die.
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors.
Before treatment starts, you will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for tests, and a urine test will be performed. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative blood (1-2 tablespoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive gemcitabine once a week, Avastin once every 2 weeks, and radiation 5 times a week. Gemcitabine and Avastin will be given on Saturdays, and the radiation will be given Monday through Friday of each week. You will receive this treatment as an outpatient for 6 weeks.
You will receive gemcitabine through a needle in a vein on Days 1, 8, 15, 22, 29, and 36 (+/- 2 days). You will receive Avastin through a needle in a vein every 2 weeks on Days 1, 15, and 29 (+/- 2 days). On the days you receive both drugs, you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
- •Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment.
- •Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.
- •There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
- •Adequate renal, and bone marrow function: Leukocytes greater than or equal to 3,000/uL; Absolute neutrophil count greater than or equal to 1,500/uL; Platelets greater than or equal to 100,000/U1; Serum creatinine less than or equal to 2.0-mg/dL and urine protein: creatinine ratio less than or equal to 1.0 at screening
- •Hepatic function (endoscopic or percutaneous drainage as needed) Total bilirubin less than or equal to 2 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than or equal to 5 X institutional ULN
- •Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
- •Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
- •Patients must sign a study-specific consent form.
排除标准
- •Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
- •Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg
- •Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- •History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study
- •Clinically significant peripheral vascular disease.
- •Known history of bleeding diathesis coagulopathy. If patient has prior documented PT, INR then INR should be less than 2.0 (patients on anticoagulation for atrial fibrillation, other cardiac disorders, and for remote history of thrombosis are not excluded). Lab results should be within 2 weeks of patient enrollment.
- •Known presence of central nervous system or brain metastases.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- •Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- •Urine protein: creatinine ratio greater than 1.0 at screening; a 24 hour urine protein should be obtained and the level must be less than 1gm/24 hours in order for the patient to be eligible.
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- •Serious, non-healing wound, ulcer, or bone fracture
- •Evidence of duodenal invasion
- •Inability to comply with study and/or follow-up procedures
- •Patients less than 18 years of age.
研究组 & 干预措施
Gemcitabine + Avastin + Surgery
Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy
干预措施: Avastin (Bevacizumab) (Drug)
Gemcitabine + Avastin + Surgery
Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy
干预措施: Gemcitabine (Drug)
Gemcitabine + Avastin + Surgery
Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy
干预措施: Radiation Therapy (Procedure)
结局指标
主要结局
Number of Patients with Resection
时间窗: 8 weeks (+/- 2 days) after the completion of chemoradiation
次要结局
未报告次要终点