A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.
详细描述
The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems. While there still is no consensus on second-line therapy. Clinical studies have demonstrated that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed cross-resistance to carboplatin and cisplatin.
Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models, which overcomes some forms of cisplatin or carboplatin resistance in preclinical tumour models. Retrospective studies also have demonstrated the efficacy of Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent SCLC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed SCLC
- •Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC
- •At least 30 days after the completion of first-line chemotherapy
- •Either sex, age between 18 to 70 years
- •Expected life time ≥ 3 months
- •Performance status ECOG grade 0-
- •Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.
- •Adequate bone marrow and organ function as defined below:
- •Neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L; AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range; Creatinineconcentration ≤120 μmol/L
- •Had measurable or assessable disease
排除标准
- •Concomitant with other malignant disease
- •Pregnancy or lactation at the time of enrollment
- •Any contraindications for chemotherapy
- •Received target therapy or immunotherapy
研究组 & 干预措施
Arm A
Chemotherapy:irinotecan plus lobaplatin
干预措施: irinotecan plus lobaplatin (Drug)
Arm B
Chemotherapy:irinotecan
干预措施: irinotecan (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: >4 weeks post treatment
Tumor Response will be evaluated using the RECIST 1.1 criteria.ORR is Partial response (PR) and complete response (CR).
次要结局
- Treatment toxicities(up to 12 months)
- Progression-free survival(PFS)(up to 12 months)
- Overall survival(OS)(up to 12 months)
研究者
ShengFa Su
Professor
Guizhou Medical University