An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan Plus Cisplatin As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented
- •Having measurable lesion(s), without previous radiation therapy.
排除标准
- •Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria).
- •Patients ever received cisplatin with total dose > 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.
研究组 & 干预措施
irinitecan/cisplatin
experimental arm consists of patients who receive irinotecan/cisplatin
干预措施: Irinotecan (Drug)
结局指标
主要结局
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
时间窗: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Tumor response according to RECIST.
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
时间窗: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Tumor response according to RECIST.
次要结局
- Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)(Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.)
- Overall Survival (OS) and Time to Tumor Progression (ITT Population)(Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.)