NCT00225784已完成2 期
A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Objective Response of Tumor by RECIST 1.0 Criteria
研究概览
简要总结
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
详细描述
The study treatment for this protocol is
- Loading dose of Cetuximab 400 mg/m2
- Weekly Cetuximab 250 mg/m2
- Bi-weekly Gemcitabine 50 mg/m2
- Daily Radiation for 28 fractions
- CT scan four weeks after completion of treatment
- Evaluation by surgeon for resectability
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
- •Histologic proof of pancreatic adenocarcinoma
- •Clinical stage I, II, or III disease
- •Radiographically measurable disease
- •Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
- •Signed protocol consent
- •Karnofsky performance status of at least 70%
- •Age > or = to 18 years
- •Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.
- •Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.
- •Creatinine < 1.5 x upper limit of normal (ULN)
- •Bilirubin < 1.5 x ULN; AST < 2.5 x ULN.
排除标准
- •Acute hepatitis or known HIV
- •Active or uncontrolled infection
- •Significant history of cardiac disease
- •Prior therapy which affects or targets the EGF pathway
- •Prior severe infusion reaction to a monoclonal antibody
- •Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents
- •Any previous chemotherapy or abdominal or pelvic radiotherapy
- •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.
- •Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
研究组 & 干预措施
Cetuximab, Gemcitabine, RT
Experimental
weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
干预措施: Cetuximab/Gemcitabine (Drug)
Cetuximab, Gemcitabine, RT
Experimental
weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
干预措施: Radiotherapy (Procedure)
结局指标
主要结局
Objective Response of Tumor by RECIST 1.0 Criteria
时间窗: one month post-therapy
Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
次要结局
- Number of Participants Assessed for Adverse Events(Participants were followed during treatment and for 30 days after completion of treatment)
- Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy(1 month after completion of treatment)
- Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.(One month post-therapy)
- Disease-Free Survival After Therapy(Five years post treatment)
- Overall Length of Survival After Therapy(Five years post treatment)
- Pattern of Failure After Therapy(Five years post treatment)
研究者
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