Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of SU5416 when combined with paclitaxel in patients with advanced malignancies.
- Determine the toxicities and pharmacokinetics of this regimen in these patients.
- Determine the effects of this regimen on a variety of histological and molecular biomarkers of angiogenesis, including in vitro activity assays of endothelial cell proliferation, migration, and invasion.
OUTLINE: This is a dose escalation study of SU5416.
Patients receive SU5416 IV over 1 hour twice weekly during the first week. During subsequent courses, SU5416 is administered on days 1, 4, 8, 11, 15, 18, 22, and 25. Paclitaxel begins on the second week of therapy and is administered IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days 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 determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven advanced malignancy for which no satisfactory treatment exists
- •Must have tumor accessible by biopsy
- •Minimum of 1 baseline biopsy required
- •No brain metastases or primary CNS tumor
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •SGOT and SGPT less than 2 times upper limit of normal unless due to presence of tumor
- •Bilirubin normal
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No uncompensated coronary artery disease by ECG or physical examination
- •No myocardial infarction or severe unstable/angina within the past 6 months
- •No severe peripheral vascular disease associated with diabetes mellitus
- •No severe deep vein or arterial thrombosis within the past 3 months
- •No pulmonary embolism within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No unstable or severe concurrent medical condition
- •No active uncontrolled infection
- •No history of allergic reaction to paclitaxel or Cremophor
- •No greater than grade 1 peripheral neuropathy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior SU5416
- •Chemotherapy:
- •No prior paclitaxel
- •Greater than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Greater than 4 weeks since prior radiotherapy and recovered
- •See Disease Characteristics
- •Recovered from any prior investigational agents
- •No other concurrent investigational agents
排除标准
- 未提供