A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis cervical cancer, to evaluate the efficacy and toxic reaction.
详细描述
Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of albumin-bound paclitaxel plus nedaplatin in patients with advanced, recurrent metastatic cervical cancer. About 30 patients will receive 175-200 mg/m2 albumin-bound paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3 weeks. At least 2 cycles will be completed for each patient, for whom responded to the treatment, 4-6 cycles will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cervical cancer, advanced or recurrent metastasis
- •Measurable and assessible tumor lesions
- •Used ordinary paclitaxel or platinum drugs, more than 28 days
- •Aged 18-70
- •KPS score> 60 points, expected to survive more than 3 months
- •Normal bone marrow function
- •The function of liver and kidney had no obvious damage
- •Normal function of vital organs
- •No brain metastases
- •Patients or their agents to sign informed consent
- •Compliance, and can be followed up regularly
排除标准
- •Brain metastases
- •Serious complications
- •Acute inflammatory response
- •Combined with other tumor
- •Pregnancy or breast-feeding women
- •Vertebral metastasis with nerve compression symptoms
- •Large volume of pleural effusion, pericardial effusion
- •Other malignancy within five years
- •Drug allergy
- •Other chemotherapy contraindications
- •The possibility of pregnancy, and not willing to contraception
- •No measurement of lesion
- •Mental illness which is difficult to control
研究组 & 干预措施
albumin-bound paclitaxel plus nedaplatin
albumin-bound paclitaxel plus nedaplatin: Intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.
干预措施: albumin-bound paclitaxel plus nedaplatin (Drug)
结局指标
主要结局
response rate
时间窗: one year
Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST
次要结局
- Time to progression (TTP)(2 years)
- 2-year progression-free survival (PFS)(2 years)
- Overall survival (OS)(5 years)
- safety and tolerability(2 years)
研究者
Zhang rong
Chief Physician
Chinese Academy of Medical Sciences