Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.
研究概览
简要总结
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
详细描述
This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.
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
- •Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or the inability to receive standard treatment due to performance status (PS>2).
- •Ascites based on paracentesis or CT scan within one month prior to enrollment
- •Life expectancy > 3 months
- •Indwelling paracentesis catheters are permitted, paracentesis is permitted at the investigators discretion
- •Negative urine pregnancy test for females
- •All subjects must agree to use birth control
- •All subjects must abstain from eating grapefruit and grapefruit juice. They must tell their physicians about any changes in their medication including over-the-counter and herbal supplements.
排除标准
- •History of congestive heart failure
- •Creatinine > 2.0
- •Pregnant or nursing
- •ALT > 2.5 times the upper limit of normal
- •Blood pressure > 160/90 (antihypertensives permitted)
- •Gastrointestinal or intra-abdominal hemorrhage within the last 6 months
- •History of QTc > 450 milliseconds
- •Brain metastasis
研究组 & 干预措施
Single Arm
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
干预措施: Sunitinib (Drug)
结局指标
主要结局
Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.
时间窗: An average of every 6 weeks
A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.
次要结局
未报告次要终点
研究者
Leah Cream
Assistant Professor of Medicine
Milton S. Hershey Medical Center