Cisplatin With Either Alimta or Gemcitabine in Long Infusion for Mesothelioma: A Randomised Phase II Trial (AGILI Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.
详细描述
Combination of pemetrexed and cisplatin is now considered the standard systemic treatment for mesothelioma. Three arguments against such a position are: 1. Pemetrexed in combination with cisplatin was registered for mesothelioma on the basis of superiority over cisplatin alone, a clearly suboptimal control arm; 2. Several Phase II trials of gemcitabine in standard doses or as low-dose in long infusion in combination with cisplatin have shown at least comparable activity; 3. Due to high cost, pemetrexed is not available to many patients in countries with limited health care resources. During the past five years, our research team in Ljubljana conducted a Phase II trial of low-dose gemcitabine (250 mg/m2) in 6-hours infusion and cisplatin for patients with mesothelioma. In an unselected population of patients including those in poor performance status, elderly, patients with advanced extrathoracic disease and patients in progression after previous chemotherapy, the response rate was 54%, and median survival was 16.5 months. On the basis of this favourable experience and in search of cost-effective treatment for mesothelioma, we here propose a randomised Phase II clinical trial to compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion. The primary endpoints are response rate and time to progression; secondary endpoints are survival, toxicity and quality of life.
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
- •histologically proven mesothelioma. While local histopathology exam is sufficient to register a patient for the trial, all biopsies will be subject to central review (please see Section 5.3.)
- •no history of other malignancy; or in complete remission for > 3 years if previously treated for other malignancy;
- •chemo-naive;
- •performance status ≥ 70% (Karnofsky); or ECOG 0 - 2 ;
- •no peripheral neuropathy grade 2 or more (common toxicity criteria - CTC, NCI), unless mechanical in origin;
- •no vascular disease grade 2 or more (NCI CTC ver.3);
- •hemoglobin > 100 g/L;
- •neutrophils > 2.0 g/L;
- •platelets > 100 x 109 /L;
- •kidney function: creatinine within normal limits + ECC > 60 mL/min; or ECC > 100 mL/min;
- •liver function: bilirubin < 1.25 x UNL; AST/ALT < 2 x UNL;
- •cardiac compensation;
- •no active infection or other serious concomitant disease;
- •women are not pregnant
- •patient's understanding of the disease and treatment and written informed consent.
排除标准
- •significant medical co-morbidity
结局指标
主要结局
Progression free survival
时间窗: CT measurement of disease will be performed after 2nd cycle of chemotherapy, at the end of the treatment and during follow up period up to progression (total average 8 months)
Efficacy of the treatment will be measured by response rate (RR) and progression free survival (PFS) using modified RECIST criteria for assessment of response in malignant pleural mesothelioma
次要结局
- Overall survival(Outcome measures will be assessed during average time period of 18 months from enrollment)