NCT00541073已完成2 期
Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Individual dosage-adapted protocol
研究概览
简要总结
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin, and vitamin B12 in patients with unresectable pleural mesothelioma.
Secondary
- Determine the relationship between pharmacokinetic and pharmacodynamic parameters (hematologic and nonhematologic).
- Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium.
- Analyze the impact of pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, XPD) variations on the toxicity of pemetrexed disodium.
- Validate a strategy of adapting dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Histologically confirmed pleural mesothelioma
- •Unresectable disease
排除标准
- •Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •WHO performance status 0-2
- •Life expectancy > 3 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine clearance > 45 mL/min
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Transaminases ≤ 3 times ULN (5 times ULN if liver metastases)
- •Not pregnant or nursing
- •Fertile patients of must use effective contraception during and for 6 months after completion of study treatment
- •Exclusion criteria:
- •Hypersensitivity to pemetrexed disodium or any of its excipients
- •Peripheral neuropathy ≥ grade 2
- •Impossible to receive study therapy due to geographical, social, familial, or psychological reasons
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •At least 28 days since prior radiotherapy (21 days for injected radiotherapy)
- •Exclusion criteria:
- •Prior chemotherapy
- •Prior yellow fever vaccine
- •Inability to discontinue aspirin (> 1.3 g/day) or NSAIDs for 2 days prior to, during, and 2 days after day 1 of each course of study therapy
- •Concurrent participation in another clinical study
结局指标
主要结局
Individual dosage-adapted protocol
次要结局
- Relationship between pharmacokinetic and pharmacodynamic parameters
- Pharmacokinetics
- Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)
研究者
研究点 (2)
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