NCT00075647已完成2 期
Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
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
- 40
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer
详细描述
PRIMARY OBJECTIVES:
I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.
SECONDARY OBJECTIVES:
I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
II. Correlate biomarkers of response with clinical response in patients treated with this drug.
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
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Locally advanced or metastatic disease
- •Radiographic evidence of disease
- •No known brain metastases
- •Performance status - ECOG 0-2
- •More than 3 months
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 50 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Fasting serum cholesterol ≤ 350 mg/dL
- •Fasting triglycerides ≤ 400 mg/dL
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •No concurrent prophylactic hematopoietic colony-stimulating factors
- •No prior chemotherapy for metastatic pancreatic cancer
- •More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer
- •Must have radiographic evidence of recurrent disease
- •More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer
- •Must have radiographic evidence of disease progression
- •See Chemotherapy
- •See Chemotherapy
- •No other concurrent investigational or commercial agents or therapies for the malignancy
- •No other concurrent anticancer therapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (temsirolimus)
Experimental
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: temsirolimus (Drug)
Treatment (temsirolimus)
Experimental
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Overall survival (OS)
时间窗: 6 months
The method of Thall and Simon will be employed.
次要结局
- Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated(Up to 2 years)
- Duration of response(From the time of objective response to the time of progressive disease, assessed up to 2 years)
- Time to progression (TTP)(From the time of the study entry to the time of relapse or progression, assessed up to 2 years)
- Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)(Up to 2 years)
- Levels of PTEN, AKT, and PI3K(Up to 2 years)
- Expression and phosphorylation status of p70s6k(Up to 7 days)
研究者
研究点 (1)
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