An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of Participants With the Indicated Response
研究概览
简要总结
This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single-arm
HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days
干预措施: topotecan (Drug)
Single-arm
HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days
干预措施: CARBOPLATIN (Drug)
结局指标
主要结局
Number of Participants With the Indicated Response
时间窗: From start of treatment to evidence of CR or PR (up to 39.3 weeks).
Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization \[WHO\] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: \>50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: \>25% increase in measurements of lesions or appearance of new lesions).
次要结局
- Time to Response(From start of treatment to evidence of PR or CR (up to 39.3 weeks))
- Duration of Response(From time of PR or CR to disease progression/death (up to 56.0 weeks))
- Progression-free Survival(From start of treatment to disease progression/death (up to 67.7 weeks))
- Number of Participants Who Died From the Start of Treatment to Follow-up(From start of treatment to death (up to 110.4 weeks).)
- The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)(Baseline to end of study (up to 54.7 weeks).)
- Time to Disease Progression(From start of treatment to disease progression/death)