A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This phase II trial is studying how well CCI-779 works in treating patients with stage IIIB non small cell lung cancer (with pleural effusion) or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. CCI-779 may also stop the growth of tumor cells by blocking the enzymes necessary for their growth.
详细描述
OBJECTIVES: Primary I. Determine the response rate in patients with stage IIIB (with pleural effusion) or IV non-small cell lung cancer treated with CCI-779.
II. Determine the clinical toxic effects of this drug in these patients.
Secondary I. Determine the 24-week progression-free survival rate in patients treated with this drug.
II. Determine the time to progression and overall survival of patients treated with this drug.
III. Evaluate predictive markers of activity (e.g., PTEN mutations and phosphoAkt expression) of this drug in these patients.
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 non-small cell lung cancer (NSCLC)
- •Stage IIIB (with pleural effusion) or IV disease
- •Measurable disease
- •At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- •The following are not considered measurable disease:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Cystic lesions
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Blood and tissue blocks available
- •Must have accessible tumor (i.e., superficial lesions such as lymph node, subcutaneous nodules) to provide core needle biopsy tissue before and during study treatment
- •No known brain metastases
- •Performance status - ECOG 0-2
- •At least 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
- •Creatinine ≤ 1.5 times ULN
- •Serum fasting cholesterol ≤ 350 mg/dL
- •Serum fasting triglycerides ≤ 400 mg/dL
- •HIV negative
- •No uncontrolled infection
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or non-invasive carcinomas
- •No concurrent severe underlying disease that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study treatment
- •No prior biologic therapy
- •No prior gene therapy
- •No prior immunotherapy
- •No concurrent immunotherapy
- •No concurrent prophylactic growth factors to support neutrophil count
- •No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
- •No other concurrent chemotherapy
- •No concurrent dexamethasone (10 mg IV)
- •No prior radiotherapy to 30% or more of bone marrow
- •Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful pre-existing bony metastasis) allowed
- •No other concurrent investigational therapy
- •No concurrent immunosuppressive therapy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.
干预措施: temsirolimus (Drug)
结局指标
主要结局
Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Up to 5 years
Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
次要结局
- Time to disease progression(Time from registration to documentation of disease progression, assessed up to 5 years)
- Progression-free survival(24 weeks)
- Survival time(Time from registration to death due to any cause, assessed up to 5 years)
- Effects of CCI-779 on mTOR as assessed by expression of 4EBP, phosphoAkt, p70S6kinase, eIF4E, cyclinD1, Her2, and EGFR(Day 8)