NCT00268918已完成1 期
A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
研究概览
简要总结
The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.
详细描述
- Patients will come to the clinic once a week to receive study treatment. To help reduce the chance of an allergic reaction patients will take Decadron tablets orally the night before, the morning of and the evening of receiving chemotherapy.
- The lead-in schedule of dosing is as follows: Day 1: Taxotere intravenously; Day 4: PTK787 orally; Day 14: Taxotere and PTK787.
- After the lead-in schedule, a cycle will consist of 28 days. PTK787 will be given orally once a day without interruption. Taxotere will be given on Day 1, Day 8, Day 15 and Day 22.
- Before each dose of Taxotere, blood tests, urine tests, and a physical exam will be done. A radiological evaluation will be done every two months. If the patients tumor remains stable or shrinks in size, they may continue to stay on the study.
- Patients should not eat grapefruit or drink grapefruit juice during this study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically.
- •Measurable disease or nonmeasurable disease
- •Age > 18 years
- •ECOG performance 0,1,2
- •4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy
- •Certain lab values
- •Negative for proteinuria
排除标准
- •Four or more treatment regimens
- •History or presence of uncontrolled CNS disease
- •Prior biologic or immunotherapies less than 3 weeks prior to registration
- •Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration
- •Prior therapy with anti-VEGF agents
- •Peripheral neuropathy with functional impairment > CTC grade 2
- •Pregnant or breast feeding
- •Concurrent severe and/or uncontrolled medical condition
- •Chronic renal disease
- •Acute or chronic liver disease
- •Impairment of gastrointestinal function or GI disease
- •Confirmed diagnosis of HIV infection are excluded at the investigators discretion
- •Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the cytochrome p450 system.
研究组 & 干预措施
Docetaxel / PTK787
Experimental
Docetaxel: Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle.
PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day.
干预措施: Docetaxel (Drug)
Docetaxel / PTK787
Experimental
Docetaxel: Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle.
PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day.
干预措施: PTK787 (Drug)
结局指标
主要结局
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
时间窗: 2 years
次要结局
- To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.(2 years)
研究者
Susana M. Campos, MD
Medical Oncologist
Dana-Farber Cancer Institute
研究点 (2)
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