A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Confirmed tumor response rate defined as the total number of evaluable patients whose objective tumor status is either a complete or partial response according to the RECIST criteria
研究概览
简要总结
This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may help paclitaxel and carboplatin kill more tumor cells by making tumor cells more sensitive to these drugs
详细描述
PRIMARY OBJECTIVE:
I. Determine the confirmed tumor response rate and adverse event profile of bortezomib, carboplatin, and paclitaxel as first-line therapy for patients with metastatic melanoma.
SECONDARY OBJECTIVE:
I. Evaluate time to tumor progression, overall survival, and duration of response.
OUTLINE: This is a multicenter study.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (bortezomib, paclitaxel, carboplatin)
Patients will receive an infusion of bortezomib twice in week 1 and once in week 2. They will also receive a 3-hour infusion of paclitaxel and an infusion of carboplatin once in week 1. Treatment may repeat every 3 weeks for as long as benefit is shown.
干预措施: carboplatin (Drug)
Treatment (bortezomib, paclitaxel, carboplatin)
Patients will receive an infusion of bortezomib twice in week 1 and once in week 2. They will also receive a 3-hour infusion of paclitaxel and an infusion of carboplatin once in week 1. Treatment may repeat every 3 weeks for as long as benefit is shown.
干预措施: paclitaxel (Drug)
Treatment (bortezomib, paclitaxel, carboplatin)
Patients will receive an infusion of bortezomib twice in week 1 and once in week 2. They will also receive a 3-hour infusion of paclitaxel and an infusion of carboplatin once in week 1. Treatment may repeat every 3 weeks for as long as benefit is shown.
干预措施: bortezomib (Drug)
结局指标
主要结局
Confirmed tumor response rate defined as the total number of evaluable patients whose objective tumor status is either a complete or partial response according to the RECIST criteria
时间窗: Assessed up to 3 years
If at most 3 of the first 19 eligible patients enrolled achieved a partial or complete response by the RECIST criteria, then enrollment would be terminated and the regimen would be considered inactive in this patient population. A 90% confidence interval will be constructed using the Duffy-Santer approach.
Adverse event profile as measured by NCI-CAE version 3.0
时间窗: Assessed up to 3 years
The maximum grade for each type of toxicity will be recorded for each patient at each evaluation. The frequency and severity of each type of toxicity will be determined overall and by course.
次要结局
- Time to disease progression(From registration to documentation of disease progression, assessed up to 3 years)
- Duration of response(From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years)
- Survival time(From registration to death due to any cause, assessed up to 3 years)