A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
研究概览
简要总结
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Some of the requirements to be in this study are:
- •Patient must be at least 18 years old.
- •Patient must have been diagnosed with non-small cell lung cancer.
- •Patient must be able to visit the doctor's office once a week.
- •Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- •Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
排除标准
- •Patients cannot participate in this study for any of the following reasons:
- •Patient has previously had chemotherapy.
- •Patient has previously had thoracic radiation therapy.
- •Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
- •Female patient is pregnant or breast-feeding.
- •Patient is unsuitable to participate in the study in the opinion of the investigator.
- •Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
研究组 & 干预措施
Pemetrexed/Cisplatin/Radiation Phase 1
Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
干预措施: Pemetrexed Phase 1 (Drug)
Pemetrexed/Cisplatin/Radiation Phase 1
Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
干预措施: Cisplatin Phase 1 (Drug)
Pemetrexed/Cisplatin/Radiation Phase 1
Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
干预措施: Radiation Therapy (Procedure)
Pemetrexed/Cisplatin/Radiation Phase 2
Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
干预措施: Radiation Therapy (Procedure)
Pemetrexed/Cisplatin/Radiation Phase 2
Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
干预措施: Pemetrexed Phase 2 (Drug)
Pemetrexed/Cisplatin/Radiation Phase 2
Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
干预措施: Cisplatin Phase 2 (Drug)
结局指标
主要结局
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
时间窗: Baseline to measured progressive disease (PD; up to 1 year)
Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy \>1 week, delay of pemetrexed/cisplatin Cycle 2 \>2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.
Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
时间窗: Baseline to date of death from any cause (up to 1 year)
OS was defined as the time from date of enrollment to death due to any cause.
次要结局
- Phase 1: Number of Participants With Adverse Events (AE; Toxicity)(Baseline to measured PD (up to 1 year))
- Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)(Baseline to measured PD (up to 3 years))
- Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years(Baseline and 2 years and 3 years)
- Phase 2: Time to Progressive Disease (PD)(Baseline to measured PD (up to 3 years))
- Phase 2: Percentage of Participants With Progression Free Survival (PFS)(Baseline and 1 year and 2 years and 3 years)
- Progression Free Survival (PFS)(Baseline to measured PD (up to 36 months))
- Phase 2: Site of Progressive Disease (PD)(Baseline to measured PD (up to 3 years))