NCT00005844已完成1 期
A Phase I Study of Oxaliplatin in Children With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors.
- Determine the toxic effects of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic or unresectable solid tumors that are not amenable to standard treatment
- •Histological confirmation not required for brain stem tumors
- •No known brain metastases
- •No leukemia
- •PATIENT CHARACTERISTICS:
- •21 and under
- •Performance status:
- •ECOG 0-2 OR
- •Lansky 50-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm^3 (except with marrow involvement)
- •Hemoglobin at least 8 g/dL
- •Platelet count at least 100,000/mm^3
- •Bilirubin 0.2-1.4 mg/dL
- •AST/ALT no greater than 3 times upper limit of normal
- •Creatinine normal for age OR
- •Creatinine clearance at least 50 mL/min
- •Electrolytes, calcium, and phosphorus normal
- •Cardiovascular:
- •No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No active graft-vs-host disease (GVHD)
- •No allergy to platinum compounds or antiemetics
- •No uncontrolled concurrent illness or infection
- •No evidence of neuropathy
- •Blood sugar normal
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior hematopoietic growth factors
- •At least 3 months since prior stem cell transplantation and recovered
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea)
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment
- •At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and Y-port radiotherapy
- •At least 6 months since prior total body irradiation
- •Not specified
- •No concurrent therapy for GVHD
- •No other concurrent anticancer investigational or commercial agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究者
研究点 (1)
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