NCT00024323已完成1 期
A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin
Vion Pharmaceuticals4 个研究点 分布在 1 个国家开始时间: 2001年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 4
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the antitumor responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cisplatin 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 confirmed progressive malignant disease that has failed at least 1 conventional treatment or is unlikely to respond to current therapy
- •Measurable or evaluable disease
- •Elevated serum tumor marker considered evaluable disease
- •No known active CNS metastases
- •Previously treated CNS metastases with no evidence of new CNS metastases allowed if stable for at least 2 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •No active bleeding or coagulation disorder (except occult blood related to gastrointestinal cancer)
- •Bilirubin no greater than 2.0 mg/dL
- •ALT and AST no greater than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 5 times ULN
- •PT and PTT no greater than 1.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No active heart disease
- •No myocardial infarction within the past 3 months
- •No symptomatic coronary artery disease
- •No uncontrolled arrhythmias
- •No uncontrolled congestive heart failure
- •No moderate to severe compromise of pulmonary function
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infectious process
- •No pre-existing severe hearing impairment
- •No grade 2 or greater neuropathy
- •No other life threatening illness
- •No prior severe allergic reaction to cisplatin
- •No mental deficits and/or psychiatric history that would preclude study
- •No persistent chronic toxic effects from prior chemotherapy greater than grade 1
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 2 weeks since prior biologic therapy
- •Chemotherapy:
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •At least 3 months since prior cisplatin or platinum analogue
- •No prior 3-AP
- •Endocrine therapy:
- •At least 2 weeks since prior hormonal therapy
- •Radiotherapy:
- •More than 3 weeks since prior radiotherapy
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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