NCT00126633已完成2 期
A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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 and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and cisplatin together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with bevacizumab works in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine time to disease progression in patients with previously untreated metastatic adenocarcinoma of the pancreas treated with gemcitabine, cisplatin, and bevacizumab.
- Determine the safety and toxicity of this regimen in these patients.
Secondary
- Determine the objective response rate in patients treated with this regimen.
- Determine the efficacy of this regimen, in terms of the proportion of patients with ≥ a 50% decline in the CA19-9 biomarker, in these patients.
- Determine the median survival of patients treated with this regimen.
- Correlate serum markers of angiogenesis and circulating tumor micrometastases with clinical outcome of patients treated with this regimen.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Must have documented extrapancreatic metastases
- •Radiographically measurable disease is not required
- •Previously untreated disease
- •No CNS or brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa [Epogen®] support allowed)
- •No evidence of bleeding diathesis or coagulopathy
- •INR ≤ 1.5 (except for patients receiving full-dose warfarin)
- •Bilirubin ≤ 2.0 mg/dL
- •AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Creatinine ≤ 2.0 mg/dL
- •Urine protein:creatinine ratio ≤ 1
- •Cardiovascular
- •No New York Heart Association class II-IV congestive heart failure
- •No myocardial infarction or stroke within the past 6 months
- •No uncontrolled hypertension (i.e., blood pressure > 160/110 mm Hg despite antihypertensive therapy)
- •No unstable angina
- •No unstable symptomatic arrhythmia requiring medication
- •Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
- •No peripheral vascular disease ≥ grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •No significant traumatic injury within the past 28 days
- •No serious non-healing wound, ulcer, or bone fracture
- •No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious systemic disease
- •No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •More than 28 days since prior major surgery, or open biopsy
- •More than 7 days since prior fine needle aspirations or core biopsies
- •No concurrent major surgery
- •No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Time to progression
Duration of response
Overall survival
Toxicity as measured by NCI CTC version 2.0
Micrometastases for predicting time to progression and overall survival
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract TumorsExtrahepatic Bile Duct CancerGallbladder CancerNCT00262769University College, London324
已完成
2 期
Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based ChemotherapyPrimary Peritoneal Cavity CancerOvarian CancerNCT00006028Gynecologic Oncology Group
已完成
2 期
Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung CancerLung CancerNCT00103051European Organisation for Research and Treatment of Cancer - EORTC
已完成
2 期
Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00326599Alliance for Clinical Trials in Oncology101
已完成
2 期
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland TumorHead and Neck CancerNCT00079079NCIC Clinical Trials Group34