A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Topical Cream (UTC) in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Incidence of Grade 2 and 3 HFS as graded by Roche Criteria
研究概览
简要总结
The purpose of this research study is to see if combining uracil cream (UTC) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects UTC and capecitabine may have in patients with metastatic breast cancer.
详细描述
Capecitabine is used in the treatment of human breast cancer among other human cancers. Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness and cracking of hands and feet. Currently, there are no approved therapies for HFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, at least 18 years old
- •Histologically or cytologically confirmed metastatic breast cancer
- •You also cannot have any ulcerations or open wounds on palms of hands or soles of feet
排除标准
- •Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier.
- •Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches.
- •The above is not a complete list of eligibility criteria. Please see your study doctor for more information.
研究组 & 干预措施
Placebo Lotion
干预措施: Cream (Drug)
0.1% Uracil
干预措施: 0.1% Uracil Cream (Drug)
结局指标
主要结局
Incidence of Grade 2 and 3 HFS as graded by Roche Criteria
时间窗: Maximum of 6 months of therapy
* Time to first HFS event * Requirements for capecitabine dose reduction/interruption due to HFS * Digital Photos will be taken of the hands and feet at specific intervals
Serum Pharmacokinetic Levels of Uracil will be drawn
时间窗: Maximum of 6 months of therapy
Pharmacokinetic levels will be drawn at specific intervals
次要结局
- Anti-Tumor efficacy of Capecitabine(Maximum of 6 months of therapy)