NCT00125021已完成2 期
A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
研究概览
简要总结
This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.
详细描述
Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
- •Only patients with measurable disease
- •ECOG performance status < or equal to 1
- •Life expectancy >12 weeks
- •Signed informed consent
- •Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.
- •>4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities
- •>4 weeks must have elapsed from the participation in any investigational drug study
- •Laboratory values:
- •ANC > 1500/mm3;
- •Hemoglobin > 9.0 gm/dl;
- •Platelets > 100,000/mm3;
- •SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).
排除标准
- •Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
- •More than one prior chemotherapy treatment regimen for metastatic disease
- •Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
- •Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- •Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders
- •Uncontrolled serious medical or psychiatric illness
- •Women must not be pregnant or lactating
- •Concurrent radiation therapy
- •Other active malignancy
- •Inability to swallow tablets
- •Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
- •Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
结局指标
主要结局
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
次要结局
- To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer(2 years)
- to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774
研究者
研究点 (6)
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