NCT00251407已完成1 期
Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
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
- 46
- 试验地点
- 3
- 主要终点
- To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
研究概览
简要总结
The purpose of this study is to find the highest dose of the combination of taxotere, cisplatin and CPT-11, that can be given without causing severe side effects. We also want to test the safety of this drug combination and see what effects (good and bad) it has on patients with advanced cancer for which there is no known curable treatment.
详细描述
- This is a Phase I clinical trial. We are unsure of the safest and most effective dose of the drugs and therefore are planning on treating 3-6 patients with a given dose before increasing to higher dose levels.
- Each patient will receive approximately two cycles of therapy. On day one and day eight, they will receive taxotere, cisplatin and CPT-11 intravenously. The cycle will begin again on day 22.
- The following tests and procedures will be performed: CAT scan prior to beginning therapy, after every 2 cycles of therapy, and at the end of the study; physical exam before each course of therapy; vital signs before and with each dose of therapy; routine blood tests before starting therapy and weekly during treatment; chest x-ray and echocardiogram before starting therapy and; toxicity assessment each week of therapy.
- Patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed, incurable solid tumor malignancy
- •18 years of age or older
- •ECOG performance status of < or = to 2
- •Life expectancy of greater than 12 weeks
- •WBC > 3,000/mm3
- •ANC > 1,500/mm3
- •Platelet count > 100,000/mm3
- •Total bilirubin within normal limits
- •SGOT < 2.5 x ULN
- •Alkaline phosphatase < 4 x ULN
排除标准
- •Prior chemotherapy for the treatment of metastatic or recurrent cancer
- •Prior radiotherapy to greater than or equal to 15% of bone marrow
- •Prior pelvic radiation therapy
- •Prior nitrosoureas or mitomycin C
- •Myocardial infarction in the past 6 months
- •Major surgery in past 2 weeks
- •Uncontrolled serious medical or psychiatric illness
- •Uncontrolled diarrhea
- •Peripheral neuropathy > grade 1
- •Pregnant or lactating women
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
研究组 & 干预措施
taxotere, cisplatin, irinotecan
Experimental
干预措施: Taxotere (Drug)
taxotere, cisplatin, irinotecan
Experimental
干预措施: Cisplatin (Drug)
taxotere, cisplatin, irinotecan
Experimental
干预措施: CPT-11 (Drug)
结局指标
主要结局
To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
时间窗: 3 years
次要结局
- To define the dose-limiting toxicities of the combination of drugs.(3 years)
研究者
Charles S. Fuchs, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (3)
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