Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
研究概览
简要总结
The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.
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
- •pathologic documentation of non-small cell lung cancer (NSCLC)
- •tumor must be accessible by bronchoscopy for tumor tissue sample collection
- •patients must have lung cancer with clinical stage IB, II, IIIA
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)
排除标准
- •bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
- •pregnant or breast feeding patients
- •patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
- •unwillingness to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
干预措施: pemetrexed (Drug)
Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
干预措施: cisplatin (Drug)
Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
干预措施: Radical Non-Small Cell Lung Cancer (NSCLC) surgery (Procedure)
结局指标
主要结局
High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
时间窗: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)
Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.
次要结局
- Percentage of Participants With Objective Tumor Response (Response Rate)(Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed))
- Duration of Response(Time of response to disease progression (up to 44.4 months))
- Disease Free Survival (DFS)(Treatment start to disease progression or death from any cause (up to 45.5 months))
- Overall Survival (OS)(Treatment start to death from any cause (up to 47.6 months))