Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
研究概览
简要总结
This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call 5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of kinase inhibitor which works by blocking proteins associated with cancer cell growth. Previous studies also suggest that midostaurin may help increase the effectiveness of radiation therapy. In this research we are looking for the highest dose of midostaurin that can be given safely in combination with standard chemoradiation.
详细描述
Midostaurin capsules will be taken by mouth for 8 weeks. For the first 2 weeks midostaurin will be taken alone (no chemoradiation). After 2 weeks standard chemoradiation will be added to the midostaurin regimen. Subjects receive midostaurin and chemoradiation for an additional 6 weeks. Physical exams will be done weekly. Blood samples will be taken and an optional tumor biopsy will be performed in week 2.
4-5 weeks after completing chemoradiation and midostaurin subjects will undergo surgery as standard of care. Tumor tissue from the surgery will be used for research purposes. A Ct scan of chest, abdomen, and pelvis will be performed.
After completion of surgery, subjects will have an end of study visit with physical exam, blood tests. CT scans of chest, abdomen, and pelvis will be performed yearly for 5 years.
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
- •Adenocarcinoma of the rectum
- •T3/4 or N+ disease
- •Life expectancy > 3 months
- •Normal organ and marrow function
排除标准
- •Metastatic disease
- •Pregnant or breastfeeding
- •Prior radiotherapy
- •Receiving other investigational agents
- •History of inflammatory bowel disease
- •Active scleroderma or CREST syndrome
- •Uncontrolled intercurrent illness
- •History of a different malignancy unless disease free for at least 5 years
- •HIV or active viral hepatitis
- •Impaired cardiac function
研究组 & 干预措施
Midostaurin with chemoradiation
干预措施: Midostaurin (Drug)
结局指标
主要结局
To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
时间窗: 1.5 years
次要结局
- To determine surgical complication rate in patients who received preoperative radiation therapy(1.5 years)
- Perform an exploratory analysis of the impact of selected mutations in APC, PTEN, BRAF, NRAS, and PIK3CA, among other genes(1.5 year)
- To evaluate proteomic markers of response and resistance to midostaurin-based chemoradiation(1.5 years)
- To determine the rate of Dworak Tumor Regression Grade 3/4 for locally advanced rectal cancer treated with study combination at the MTD, stratified by KRAS status (mutant vs. wild type)(1.5 years)
研究者
Theodore Sunki Hong
Radiation Oncologist
Massachusetts General Hospital