A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Response rate as measured by RECIST criteria
研究概览
简要总结
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with sorafenib and gemcitabine.
II. Determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with sorafenib plus gemcitabine.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Locally advanced or metastatic disease
- •Locally advanced disease must extend outside the boundaries of a standard radiotherapy 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 effusion and ascites are not considered measurable lesions
- •Outside prior radiotherapy port
- •No known brain metastases
- •Performance status - ECOG 0-1
- •Performance status - Karnofsky 70-100%
- •More than 3 months
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No evidence of bleeding diathesis
- •Bilirubin normal
- •AST and/or ALT ≤ 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance ≥ 60 mL/min
- •No uncontrolled hypertension
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active or ongoing infection
- •No other active malignancy
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No prior antiangiogenic agents
- •No prior cytotoxic chemotherapy for metastatic disease
- •At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No prior gemcitabine
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior investigational drugs
- •No prior sorafenib
- •No prior MAPK signaling agents
- •Concurrent warfarin anticoagulation allowed provided the following criteria are met:
- •Therapeutic on a stable warfarin dose
- •Undergo weekly INR testing
- •No active bleeding or pathological condition that carries a high risk of bleeding
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
- •No other concurrent anticancer therapies
排除标准
- 未提供
研究组 & 干预措施
Treatment (sorafenib tosylate and gemcitabine hydrochloride)
Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: sorafenib tosylate (Drug)
Treatment (sorafenib tosylate and gemcitabine hydrochloride)
Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Response rate as measured by RECIST criteria
时间窗: Up to 6 months
次要结局
- Overall survival(Up to 6 months)
- Progression free survival(From start of treatment to progression or death, assessed up to 6 months)
- Survival(At 6 months)