NCT00541021Unknown3 期
Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival.
Secondary
- Compare toxicities.
- Compare response rate.
- Compare overall survival.
- Evaluate clinical benefits.
- Compare quality of life.
- Identify biomarkers that predict therapeutic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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:
- •Inclusion criteria:
- •Diagnosis of adenocarcinoma of the pancreas
- •Locally advanced or metastatic disease
- •Measurable disease, defined as at least 1 lesion measurable by RECIST criteria
排除标准
- •Brain metastases
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •WHO performance status 0-2
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Creatinine < 1.5 times normal
- •Transaminases < 2 times normal (5 times normal if liver metastases)
- •Total bilirubin < 1.5 times normal
- •Fertile patients must use effective contraception
- •Exclusion criteria:
- •Pregnant or nursing
- •Intestinal occlusion
- •Prior inflammatory intestinal disease
- •Crohn's disease
- •Hemorrhagic rectal colitis
- •Peripheral neuropathy > grade 2
- •Other severe illness, including any of the following:
- •Unstable cardiac disease, even if treated
- •Psychological or neurological disease including dementia
- •Uncontrolled active infection
- •Other severe illness that would compromise study participation
- •Impossible to receive study therapy due to geographical, social, or psychological reasons
- •Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •See Disease Characteristics
- •At least 6 months since prior chemotherapy or radiochemotherapy
- •At least 4 weeks since prior radiotherapy and/or surgery
- •Exclusion criteria:
- •Prior therapy for advanced disease
- •Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase)
- •Prior inhibitors of angiogenesis (e.g., bevacizumab)
- •Prior organ graft or allogeneic transplantation
- •Prior extensive intestinal resection
- •Concurrent participation in another therapeutic study
- •Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin)
结局指标
主要结局
Progression-free survival
次要结局
- Overall survival
- Clinical benefits
- Quality of life by QLQ-C30
- Biomarkers of response
- Response rate
- Toxicities
研究者
研究点 (2)
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