A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without MK-0646 as First-Line Therapy in Advanced Squamous Non-Small Cell Lung Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, 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 MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and carboplatin are more effective when given together with or without MK-0646 in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well gemcitabine hydrochloride and carboplatin work when given together with or without MK-0646 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess and compare the progression-free survival of patients with stage IIIB or IV squamous cell non-small cell lung cancer treated with gemcitabine hydrochloride and carboplatin with vs without MK-0646 as first-line therapy.
Secondary
- To assess and compare the objective tumor response rate in patients treated with these regimens.
- To assess and compare the duration of response in patients with objective tumor response treated with these regimens.
- To assess and compare the time to progression and time to treatment failure in patients treated with these regimens.
- To assess and compare the 1-year overall survival of patients treated with these regimens.
- To assess and compare the clinical toxicities of these regimens in these patients.
- To compare the quality of life of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and MK-0646 IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with stable disease or partial or complete response may then receive MK-0646 alone on days 1 and 15. Treatment with MK-0646 repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: dalotuzumab (Biological)
Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and MK-0646 IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with stable disease or partial or complete response may then receive MK-0646 alone on days 1 and 15. Treatment with MK-0646 repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: carboplatin (Drug)
Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and MK-0646 IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with stable disease or partial or complete response may then receive MK-0646 alone on days 1 and 15. Treatment with MK-0646 repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: gemcitabine hydrochloride (Drug)
Arm II
Patients receive gemcitabine hydrochloride and carboplatin as in arm I. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may crossover to arm upon disease progression.
干预措施: carboplatin (Drug)
Arm II
Patients receive gemcitabine hydrochloride and carboplatin as in arm I. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may crossover to arm upon disease progression.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to 5 years
次要结局
- Time to treatment failure(Up to 5 years)
- Toxicity according to NCI CTCAE v.3(Up to 5 years)
- Response rate, defined as complete or partial response noted as the objective status on 2 consecutive evaluations at least 6 weeks apart(Up to 5 years)
- Overall survival(Up to 5 years)
- Quality of life using single-item Linear Analogue Self Assessment (single-item LASA) and single-item measure for fatigue at baseline, at the end of courses 2 and 4, and at the end of treatment(Up to 5 years)
- Time to disease progression(Up to 5 years)
- Duration of response(Up to 5 years)