An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cutaneous malignant melanoma;
- •advanced, inoperable stage IV melanoma;
- •measurable and/or evaluable sites of metastases.
排除标准
- •prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
- •prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
- •clinically significant cardiovascular disease;
- •ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: fotemustine (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR)
时间窗: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)
时间窗: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.
次要结局
- Duration of CR - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Duration of Overall Response of CR or PR - Time to Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Overall Survival (OS) - Percentage of Participants With an Event(Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months))
- Time to Progression (TTP) - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- TTP - Time to Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Duration of CR - Time to Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Duration of Overall Response of CR or PR - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Duration of Stable Disease - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Time to Treatment Failure (TTF) - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- TTF - Time to Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Duration of Stable Disease - Time to Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- OS - Time to Event(Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months))
- Time to CR - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Time to CR - Time To Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Time to Overall Response of CR or PR - Percentage of Participants With an Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)
- Time to Overall Response of CR or PR - Time to Event(Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months)