A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.
详细描述
OBJECTIVES:
I. Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib.
II. Compare the toxicity of these regimens in these patients. III. Compare median progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center (University of Chicago vs other) and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 or cytologically confirmed adenocarcinoma of the pancreas
- •Advanced disease
- •Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port
- •Not amenable to curative surgery or radiotherapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Pleural effusions and ascites are not considered measurable lesions
- •No CNS disease, including primary brain tumors or brain metastasis
- •No tumor invasion into the duodenum
- •Performance status - ECOG 0-2
- •More than 3 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,000/mm^3
- •No history of bleeding diatheses
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •INR ≤ 1.5 (≤ 3 for patients on warfarin)
- •No esophageal varices
- •Creatinine ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 60 mL/min
- •Urine protein < 1+
- •24-hour urine protein < 500 mg
- •No history of a recent cerebrovascular accident
- •No clinically significant cardiovascular disease
- •No uncontrolled hypertension
- •No New York Heart Association class II-IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No peripheral vascular disease ≥ grade II
- •None of the following arterial thromboembolic events within the past 6 months:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study participation
- •HIV negative
- •No significant traumatic injury within the past 28 days
- •No gastrointestinal tract disease resulting in an inability to take oral medication
- •No allergic reactions to compounds similar to bevacizumab, cetuximab, or erlotinib (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
- •No serious or non-healing wound, ulcer, or bone fracture
- •No active infection requiring antibiotics
- •No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No prior bevacizumab or cetuximab
- •No other prior vascular endothelial growth factor inhibitors
- •No prior gemcitabine
- •No prior cytotoxic chemotherapy for metastatic disease
- •At least 4 weeks since prior adjuvant chemotherapy (6 weeks for mitomycin or nitrosoureas)
- •At least 4 weeks since prior radiotherapy
- 另有 19 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab)
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
干预措施: cetuximab (Biological)
Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab)
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
干预措施: gemcitabine hydrochloride (Drug)
Arm I (cetuximab, gemcitabine hydrochloride, bevacizumab)
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
干预措施: bevacizumab (Biological)
Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
干预措施: gemcitabine hydrochloride (Drug)
Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
干预措施: bevacizumab (Biological)
Arm II (gemcitabine hydrochloride, bevacizumab, erlotinib)
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
干预措施: erlotinib hydrochloride (Drug)
结局指标
主要结局
Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Up to 6 months
次要结局
- Progression-free Survival(36 months)
- Overall Survival(36 months)