NCT00253526撤回2 期
Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, 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 an 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. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without bevacizumab.
Secondary
- Compare overall survival in patients treated with these regimens.
- Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to establish prognostic indicators for response in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •No evidence of distant metastasis on laparoscopy
- •No superior mesenteric artery or thrombosed superior mesenteric vein involvement
- •Superior mesenteric vein or portal vein involvement allowed
- •Evidence of a pancreatic mass by radiographic or endoscopic examination
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 2,500/mm^3
- •Absolute neutrophil count ≥ 1,250/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hepatitis B surface antigen negative
- •Hepatitis C virus negative
- •No history of hepatic cirrhosis
- •Creatinine ≤ 2.0 mg/dL
- •Proteinuria negative or trace by urinalysis OR
- •Protein < 1 g on 24 hr urine collection
- •No active gross hematuria
- •Cardiovascular
- •No severe congestive heart failure
- •No active ischemic heart disease
- •No ischemic changes on a cardiac thallium stress test
- •No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy)
- •No active coagulation disorder
- •No active gross hemoptysis
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during the adjuvant therapy part of trial
- •HIV negative
- •No active infection
- •No wound healing problem from recent invasive procedure
- •No significant history of medical illness that would preclude patient from undergoing an operative procedure
- •No other malignancy requiring systemic therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Recovered from prior immunotherapy for pancreatic cancer
- •No prior bevacizumab
- •Chemotherapy
- •Recovered from prior chemotherapy for pancreatic cancer
- •No prior gemcitabine hydrochloride
- •Endocrine therapy
- •Recovered from prior hormonal therapy for pancreatic cancer
- •Radiotherapy
- •Recovered from prior radiotherapy for pancreatic cancer
- •No prior radiotherapy to the pancreas
- •No prior definitive resection of the primary pancreatic tumor
- •Prior surgery, other than resection of the primary tumor, allowed
- 另有 2 项未显示
排除标准
- 未提供
研究者
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