Phase II-III, Factorial Multicenter Randomized Trial Evaluating the Addition of Rofecoxib to Polycht With Cispatin and Gemcitabine and Fixed Dose Rate Infusion of Gem in Association With Cisplatin in 1st-line for Advanced NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 25
- 主要终点
- To evaluate the tolerability of three experimental treatment schedules
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.
详细描述
The primary end-points of the GECO study
- To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC
- To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC
- To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30 minutes, in combination with cisplatin, in the treatment of patients affected by advanced NSCLC
Four treatment arms are planned.
- ARM A standard treatment : cisplatin + gemcitabine
- ARM B cisplatin + gemcitabine + rofecoxib
- ARM C cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute)
- ARM D cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib
The phase II part of the study for experimental arms B, C and D will be conducted to evaluate tolerability in the three treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologic or histologic diagnosis of non-small cell lung cancer
- •Disease stage IIIB or IV
- •Age less than 70 years
- •ECOG performance status 2 or less
- •Patients with cerebral metastases are permitted if they are asymptomatic and do not require radiation therapy concomitant with chemotherapy
- •Negative history of allergy to non-steroidal anti-inflammatory and/or sulphonamide drugs
- •Patients previously treated with radiation therapy are permitted if at least 4 weeks have passed since last therapy
- •Written informed consent
排除标准
- •Previous chemotherapy
- •Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
- •Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
- •Creatinine > 1.25 x the upper normal limits
- •GOT and/or GPT and/or Bilirubin > 1.25 the upper normal limits in absence of hepatic metastases
- •GOT and/or GPT and/or Bilirubin > 2.5 the upper normal limits in presence of hepatic metastases
- •Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- •Inability to comply with follow-up
研究组 & 干预措施
cisplatino plus gemcitabine
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
干预措施: gemcitabine (Drug)
cisplatino plus gemcitabine
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
干预措施: cisplatin (Drug)
cisplatino plus gemcitabine plus rofecoxib
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
干预措施: gemcitabine (Drug)
cisplatino plus gemcitabine plus rofecoxib
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
干预措施: cisplatin (Drug)
cisplatino plus gemcitabine plus rofecoxib
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
干预措施: rofecoxib (Drug)
cisplatino plus gemcitabine 10 mg/m2/min
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
干预措施: prolonged continuous infusion gemcitabine (Drug)
cisplatino plus gemcitabine 10 mg/m2/min
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
干预措施: cisplatin (Drug)
cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
干预措施: prolonged continuous infusion gemcitabine (Drug)
cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
干预措施: cisplatin (Drug)
cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
干预措施: rofecoxib (Drug)
结局指标
主要结局
To evaluate the tolerability of three experimental treatment schedules
时间窗: at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration
adverse events according to CTCAE criteria
To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy
时间窗: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).
response rate according to RECIST criteria
To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin
时间窗: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).
response rate according to RECIST criteria
次要结局
未报告次要终点