A Phase II Trial of Docetaxel Plus Cetuximab and Docetaxel Plus Bortezomib (NSC #681239, IND #58443) in Advanced Non-Small Cell Lung Cancer Patients With Performance Status (PS) 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This randomized phase II trial is studying how well giving docetaxel together with either cetuximab or bortezomib works as first-line therapy in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy in treating non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the progression free survival (PFS), defined as the time between study entry and disease progression or death, for each of the two combination regimens.
SECONDARY OBJECTIVES:
I. To determine the overall response rate of each regimen. II. To evaluate the overall survival distributions associated with each regimen.
III. To evaluate the toxicities of each regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All patients must have histologically or cytologically documented non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types)
- •Patients with stage IV disease are eligible
- •Patients with stage IIIB due to a malignant pleural effusion or supraclavicular node involvement are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and thoracic radiotherapy are not eligible)
- •Patients with known CNS metastases who have received therapy (surgery, XRT, gamma knife), and are neurologically stable and off steroids by the time of enrollment are eligible if they are not on enzyme-inducing anticonvulsants; patients with leptomeningeal disease are not eligible
- •Documentation of PS 2 must be noted on form C-1392
- •Patients must have measurable or non-measurable disease
- •Measurable disease (target lesions): lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- •Non-measurable disease (non-target lesions): all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following:
- •Bone lesions
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •No prior systemic treatment for advanced NSCLC is permitted; prior treatment for early-stage disease (adjuvant) or for locally-advanced stage III disease is allowed if completed at least 12 months prior to registration
- •Patients must have recovered (all toxicities ≤ grade 1) from prior surgery and/or radiotherapy
- •No prior therapy which specifically and directly targets the EGFR pathway
- •No prior severe infusion reactions to a monoclonal antibody
- •No ≥ grade 2 peripheral neuropathy
- •Non-pregnant and non-nursing
- •No concurrent treatment with any other investigational therapy
- •Granulocytes ≥ 1,500/μl
- •Platelets ≥ 100,000/μl
- •Serum creatinine ≤ ULN
- •Bilirubin ≤ ULN
- •AST ≤ ULN
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cetuximab IV over 1-2 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive cetuximab alone as above in the absence of disease progression or unacceptable toxicity.
干预措施: docetaxel (Drug)
Arm I
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cetuximab IV over 1-2 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive cetuximab alone as above in the absence of disease progression or unacceptable toxicity.
干预措施: cetuximab (Biological)
Arm II
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive bortezomib alone as above in the absence of disease progression or unacceptable toxicity.
干预措施: docetaxel (Drug)
Arm II
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive bortezomib alone as above in the absence of disease progression or unacceptable toxicity.
干预措施: bortezomib (Drug)
结局指标
主要结局
PFS
时间窗: Time between randomization and initial failure (disease progression or death), assessed up to 6 months
The product limit estimator developed by Kaplan and Meier will be used.
次要结局
- Overall response rate(Up to 6 years)
- Overall survival(Time between randomization and death, assessed up to 6 years)