A Phase II Study of G3139 in Combination With Doxorubicin in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Rate of objective response (complete and partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with doxorubicin in treating patients who have locally advanced, recurrent, or metastatic hepatocellular carcinoma (liver cancer).
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of oblimersen and doxorubicin in patients with advanced hepatocellular carcinoma or other incurable solid tumor (closed to accrual as of 11/7/03). (Phase I completed as of 1/16/04.)
- Determine the efficacy of this regimen, in terms of objective response rate, in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression, response duration, progression-free survival, median survival, and overall survival rates in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. (Phase I completed as of 1/16/04.)
Patients receive oblimersen IV continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen and doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients*, including 6 patients with hepatocellular carcinoma (HCC), are treated at the recommended phase II dose. (Phase I completed as of 1/16/04.)
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 120 Years（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
G3139 in combination with Doxorubicin
干预措施: oblimersen sodium (Biological)
G3139 in combination with Doxorubicin
干预措施: doxorubicin hydrochloride (Drug)
结局指标
主要结局
Rate of objective response (complete and partial)
时间窗: Up to 280 days
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Objective response rate of \>= 30% is considered active, and \<10% is considered inactive.
次要结局
- Progression-free survival rate(Up to 280 days)
- Median survival rate(Up to 280 days)
- Overall survival rate(Up to 280 days)
- Safety and tolerability(Up to 280 days)
- Stable disease rate(Up to 280 days)
- Duration of response(Up to 280 days)