Phase 1/2 Study of Pemetrexed (Alimta) Plus Carboplatin, or Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Pemetrexed Consolidation in Patients With Favorable-Prognosis Inoperable Stage IIIA/B Non-Small-Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin
研究概览
简要总结
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
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
- •Inoperable non small cell lung cancer
- •No weight loss greater than 10% in 3 months prior to enrolling in trial
- •Adequate kidney function
- •Adequate liver function
- •Adequate lung function
排除标准
- •Previous surgery to remove lung tumor
- •Previous chemotherapy or radiation therapy or lung cancer
- •Inability to take vitamin supplementation
- •Heart attack within past 6 months
- •Active infection
研究组 & 干预措施
A: Pemetrexed + Carboplatin
Pemetrexed + Carboplatin
干预措施: pemetrexed (Drug)
A: Pemetrexed + Carboplatin
Pemetrexed + Carboplatin
干预措施: carboplatin (Drug)
A: Pemetrexed + Carboplatin
Pemetrexed + Carboplatin
干预措施: radiation therapy (Radiation)
B: Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
干预措施: pemetrexed (Drug)
B: Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
干预措施: cisplatin (Drug)
B: Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin
时间窗: Phase 1 enrollment to the end of study treatment up to Week 11
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (\<0.5 x 10\^9 cells per liter) lasting \>7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever \>38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin
时间窗: Phase 1 enrollment to the end of study treatment up to Week 11
MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (\<0.5 x 10\^9 cells per liter) lasting \>7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever \>38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).
Phase 2 - Survival Probability at 2 Years
时间窗: Phase 2 randomization up to 2 years
次要结局
- Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)(Phase 1 enrollment up to Week 11)
- Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)(Phase 1 enrollment to the end of the study treatment up to Week 11)
- Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events(Phase 2 randomization to the end of the study treatment up to 30.0 months)
- Phase 2 - Time to Progression(Phase 2 randomization to measured disease progression up to 24 months)
- Phase 2 - Median Survival(Phase 2 randomization to death as the result of any cause up to 30.0 month)
- Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)(Phase 2 randomization to the end of the treatment up to 30.0 months)