Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.
研究概览
简要总结
The primary purpose of this study is to determine the best dosage of Capecitabine and Tarceva combination in the setting of radiation and to assess treatment effectiveness, progression-free survival and overall survival.
详细描述
Over the past several decades, 5-fluorouracil based chemoradiation has been the cornerstone for the treatment of locally advanced non-operable pancreatic cancer. However, the survival of these patients is disappointing. The majority of the patients suffer either local progression or metastatic disease. With the availability of Capecitabine, a few pilot studies showed the the drug is convenient, tolerable and safe in combination with radiation therapy. Capecitabine demonstrated its superior anti-tumor activity with 14 months of median survival. However, these are small Phase I studies and the survival benefit needs to be further validated with larger studies. Epidermal growth factor receptor (EGFR) has been implicated in tumor growth and angiogenesis. Inhibiting EGFR by Tarceva has demonstrated effective treatment in metastatic pancreatic cancer. Anti-epidermal growth factor therapy in combination with radiotherapy has been demonstrated efficacious in other solid tumors such as head and neck cancer. We hypothesize that the combination of Tarceva and Capecitabine has synergistic anti-tumor effect. Hence, improvement of median survival could be potentially achieved with this novel combination.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of adenocarcinoma of the pancreas that is locally advanced & not amenable to resection with curative intent.
- •Must not have received prior systemic therapy for locally advanced disease.
- •ECOG performance status must be 0-
- •Adequate hepatic, renal & bone marrow function.
- •Radiographic evidence of disease is required.
- •Life expectancy > 12 weeks.
排除标准
- •Prior treatment with Capecitabine & other EGFR inhibitor.
- •Patients with GI tract disease resulting in an inability to take oral medications.
- •Significant GI disorders with diarrhea as a major symptom.
- •Uncontrolled intercurrent illness including active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias now well controlled with medication, myocardial infarction within the previous 6 months, psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with metastases.
- •Patients who have had chemotherapy.
- •Patients may not be receiving any other investigational agents, or have participated in any investigational drug study.
- •Extensive symptomatic fibrosis of the lungs.
- •Females who are pregnant or lactating.
- •History of any other malignancy in the last 2 years, except prior history of in situ cancer, basal or squamous cell skin cancer are eligible.
- •Known DPD deficiency.
- •Receiving therapeutic doses of Coumarin-derivative anticoagulant therapy. Patients requiring anticoagulation who may be safely switched to LMWH are eligible.
研究组 & 干预措施
Single arm
This is a single arm dose escalation study with a cohort expansion.
干预措施: Capecitabine, Tarceva (Drug)
结局指标
主要结局
To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.
时间窗: Two years
次要结局
- To assess treatment efficacy and overall survival.(Two years)