NCT00036790已完成1 期
An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
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. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Evaluate the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.
Group A:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and 10 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment repeats every 21 days.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced malignancy that is considered incurable
- •Recurrent or metastatic disease
- •Relapsed solid tumors include, but are not limited to the following sites:
- •Head and neck
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST and ALT no greater than 2 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •LVEF greater than 45% at rest
- •No prior myocardial infarction
- •No congestive heart failure
- •No clinically significant ventricular arrhythmias
- •No history of HIV infection
- •No history of porphyria
- •No glucose-6-phosphate dehydrogenase deficiency
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 28 days since prior chemotherapy
- •No prior lifetime cumulative doxorubicin exposure of more than 300 mg/m^2
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 28 days since prior radiotherapy
- •No concurrent radiotherapy
- •No concurrent surgery
- •At least 14 days since prior multidrug resistance-modulating drugs (e.g., PSC833 or cyclosporine)
- •No other concurrent antineoplastic or investigational agents
排除标准
- 未提供
研究者
研究点 (2)
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