NCT00827580终止1 期
A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.
研究概览
简要总结
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).
详细描述
Primary Objectives
- To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
- To assess any eniluracil dose response relationship in prevention of HFS.
- To evaluate any potential toxicity of eniluracil ointment.
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
- Double
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
- •A subject will be eligible for inclusion in this study ONLY if ALL of the following criteria apply:
- •Signed written informed consent.
- •Male or female, at least 18 years of age.
- •Histologically or cytologically confirmed diagnosis of breast or colon cancer.
- •Radiologically documented measurable disease
- •Planned to receive capecitabine at 1000-1250 mg/m2 PO twice daily and has experienced grade 1 or greater HFS on a previous cycle of capecitabine.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at study entry.
- •Adequate liver function with SGOT and SGPT < 2.5 times upper limits of normal.
- •Adequate bone marrow function evidence by WBC > 2500/mm3, PMN >2000/mm3 and platelet count > 100,000/mm
- •Adequate renal function with serum creatinine < 1.7 mg/dl.
- •Recovery from relevant toxicity before study entry.
- •Negative serum or urine pregnancy test within 7 days before study entry for women of childbearing potential. Effective contraception throughout the course of the study for both male and female subjects if the risk of conception exists.
排除标准
- •A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- •Known DPD deficiency
- •Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
- •History of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for >28 days.
- •Stroke, major surgery, or other major tissue injury within 30 days before study entry.
- •Myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ECG abnormalities.
- •No concurrent or planned use of topical pharmaceuticals to the hands or feet other than Aquaphor®.
- •No concurrent or planned use of cytotoxic drugs (other than capecitabine).
- •No other dermatologic condition that may complicate evaluation of the study.
- •Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic.
- •Breast feeding or lactating.
- •Unable to return at the regular required intervals for reassessment or study drug administration.
- •Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian.
- •Allergy to lanolin
研究组 & 干预措施
Eniluracil
Experimental
干预措施: Eniluracil (Drug)
结局指标
主要结局
the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.
次要结局
未报告次要终点
研究者
研究点 (1)
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