NCT00191334已完成2 期
Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Best Overall Tumor Response
研究概览
简要总结
The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line 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
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG = 0-2
- •Operated patients
- •disease stage III-IV
排除标准
- •No prior chemotherapy or radiation therapy
研究组 & 干预措施
A
Experimental
干预措施: gemcitabine (Drug)
A
Experimental
干预措施: cisplatin (Drug)
结局指标
主要结局
Best Overall Tumor Response
时间窗: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up
Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
次要结局
- Duration of Response(every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up)
- Time to Progressive Disease(every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up)
- Time to Treatment Failure(every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up)
- Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade(every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Combination Chemotherapy for Metastatic Breast CancerBreast CancerNCT00191815Eli Lilly and Company70
已完成
2 期
GEM vs GEM+TS-1 for Advanced Pancreatic CancerPancreatic CancerNCT00514163Japan Clinical Cancer Research Organization110
已完成
2 期
Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial CancerEndometrial CancerNCT00388154M.D. Anderson Cancer Center21
已完成
2 期
Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial CarcinomaUrothelial CarcinomaNCT01261728Memorial Sloan Kettering Cancer Center57
已完成
2 期
A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal CancerRectal CancerNCT02694718Hoffmann-La Roche60