NCT00673504已完成2 期
Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer
Central European Society for Anticancer Drug Research11 个研究点 分布在 2 个国家目标入组 105 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 11
- 主要终点
- Time to Progression
研究概览
简要总结
Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.
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
- •Patients who suffer from locally advanced or metastatic pancreatic cancer
- •Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
- •ECOG performance status 0 to 1
- •Signed written informed consent.
- •White blood cell count (WBC) >= 3x10^9/L with neutrophils >= 1.5 x 10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 5.6 mmol/L (9 g/dL).
- •Total bilirubin < 2 x upper limit of normal.
- •AST and ALT < 2.5 x upper limit of normal, or < 5 x upper limit of normal in case of liver metastases.
- •Serum creatinine < 1.5 x upper limit of normal
- •Normal ECG without QT prolongation
排除标准
- •Resectable pancreatic cancer
- •Previous chemotherapy (for adjuvant or metastatic disease)
- •Any investigational drug within the 30 days before inclusion.
- •Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
- •Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
- •Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
- •Clinically symptomatic brain or meningeal metastasis. (known or suspected)
- •Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
- •History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) > NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism
- •Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
- •Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
- •History of organ allograft
- •Patients requiring long-term cortisone therapy
- •Patients requiring oral anticoagulation treatment (such as marcoumar)
研究组 & 干预措施
A
Experimental
Gemcitabine + Sunitinib
干预措施: Gemcitabine + Sunitinib (Drug)
B
Other
Gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Time to Progression
时间窗: once all patients completed treatment
次要结局
- Response Rate (RR)(once all patients completed treatment)
- overall survival(at study end)
- Safety(at study end)
研究者
研究点 (11)
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