NCT00059917已完成1 期
Phase I Study of CT-2106 in Patients With Advanced Malignancy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged.
PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in patients with advanced malignancies.
- Determine the tolerability of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the disease response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive polyglutamate camptothecin (CT-2106) IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond confirmation of complete response.
Cohorts of 3-6 patients receive escalating doses of CT-2106 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 advanced malignancy
- •No active brain metastases (as indicated by clinical symptoms, cerebral edema, or progressive tumor growth) that have been unstable for at least 8 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine no greater than 1.5 times ULN
- •No history of hemorrhagic cystitis
- •No history of microscopic hematuria associated with drug therapy or radiotherapy or of unknown origin
- •Cardiovascular
- •No significant cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to comply with study schedule and assessments
- •No other significant nonmalignant systemic disease
- •No active infection
- •No other condition that would in the investigator's opinion make the patient an inappropriate study candidate
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 3 prior chemotherapy regimens
- •More than 4 weeks since prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior definitive radiotherapy (except for palliative reasons to sites of nonmeasurable disease, in patients with measurable disease at baseline)
- •Concurrent palliative radiotherapy allowed
- •More than 4 weeks since prior major thoracic or abdominal surgery
- •Recovered from prior therapy (except alopecia or stable grade 1 neuropathy)
- •More than 4 weeks since prior investigational agents
- •No prior myeloablative therapy
排除标准
- 未提供
研究者
研究点 (1)
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