Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Median time until treatment is stopped due to renal function ≤ 45mL / min
研究概览
简要总结
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.
The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.
详细描述
- Primary objective: Evaluate the impact of calculating the dose of pemetrexed to be administered versus creatine clearance according to Cockcroft-Gault (CrCLCG) versus body surface area (SC) on median time before discontinuation of treatment for renal function ≤ 45mL / min in patients treated for non-small cell lung cancer predominantly non-squamous in maintenance.
- Secondary objective: To evaluate the impact of calculating the dose of pemetrexed to be administered versus CRCLCG versus SC over time to treatment discontinuation, progression-free survival (PFS), and patient overall survival.
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
- •Patient over 18 years of age
- •Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented
- •Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed
- •Neutrophils> 1500 / mm3; Chips> 100,000 / mm3
- •Informed, dated and signed consent For patients of childbearing age, effective contraceptive method
- •Creatinine clearance according to the Cockcroft-Gault formula between 70 and 45 mL / min
- •PS = 0 or 1
排除标准
- •Patient with a contraindication to pemetrexed therapy
- •Patient with symptomatic brain metastases
- •Pregnant or nursing women
- •Patient under guardianship or curatorship or subject to a system of protection for persons of full age
- •Patient not affiliated to a social security scheme (beneficiary or beneficiary)
研究组 & 干预措施
STANDARD ARM
Calculation of the dose of pemetrexed as a function of body surface area
干预措施: Pemetrexed (Drug)
EXPERIMENTAL ARM
Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Median time until treatment is stopped due to renal function ≤ 45mL / min
时间窗: 1 year
From date of randomization until the date of treatment is stopped
次要结局
- Progression-free survival(up to 100 weeks)