SU5416, Irinotecan, and Cisplatin in Treating Patients With Advanced Solid Tumors
Phase I Study of SU5416 in Combination With CPT-11 and Cisplatin in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow to the tumor. Combining SU5416 with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in treating patients who have advanced solid tumors.
研究概览
详细说明
OBJECTIVES: I. Determine the maximum tolerated dose of SU5416 in combination with irinotecan and cisplatin in patients with advanced solid tumors. II. Determine the quantitative and qualitative toxicity of this treatment regimen in terms of organ specificity, time course, predictability, and reversibility in this patient population. III. Determine the therapeutic response of this treatment regimen in these patients. IV. Evaluate the clinical pharmacokinetics and the relationship of kinetics to toxicity and response in this patient population treated with this regimen.
OUTLINE: This is a dose escalation study of SU5416. Patients receive cisplatin IV over 90 minutes immediately followed by irinotecan IV over 90 minutes and SU5416 IV over 2 hours on day 1. Patients receive SU5416 alone on day 4. Patients receive combination chemotherapy weekly for 4 weeks and SU5416 twice weekly for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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Ohio
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Columbus、Ohio、美国、43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor for which no curative therapy exists No prior or concurrent primary brain tumor or brain metastasis
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 No inherited predisposition to hypercoagulation Hepatic: Bilirubin normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination No myocardial infarction or severe unstable angina within the past 6 months No severe peripheral vascular disease related to diabetes mellitus No deep venous or arterial thrombosis within the past 3 months No inherited predisposition to thrombosis Pulmonary: No pulmonary embolism within the past 3 months Other: No other malignancies within the past 5 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix No other significant medical illness No serious active infections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No other concurrent chemotherapy No prior cisplatin or irinotecan Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: No other concurrent investigational drugs
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CDR0000068008
- OSU-00H0033
- NCI-47
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