NCT00022594已完成2 期
Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields
European Organisation for Research and Treatment of Cancer - EORTC40 个研究点 分布在 10 个国家目标入组 50 人开始时间: 2001年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 40
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 II trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck.
- Determine the objective response, duration of response, and time to progression in patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of a target lesion in a previously irradiated field (within vs outside).
Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks.
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 squamous cell carcinoma of the head and neck
- •Metastatic or loco-regionally recurrent disease
- •No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas
- •No tumors of the nasal or paranasal cavities or of the nasopharynx
- •Measurable disease
- •No clinical symptomatic evidence of brain or leptomeningeal metastases
- •Ineligible for loco-regional treatment after chemotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 times ULN
- •No uncontrolled hypercalcemia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 30 days after study
- •No known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug
- •No uncontrolled systemic disease or infection
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •No other prior or concurrent malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent anticancer biological therapy or immune response modifiers
- •No concurrent prophylactic hematopoietic growth factors
- •Chemotherapy:
- •See Disease Characteristics
- •No prior chemotherapy for recurrent disease
- •No prior therapy with camptothecin analogues
- •At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy
- •No other concurrent anticancer cytotoxic therapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 8 weeks since prior radiotherapy and recovered
- •Not specified
- •At least 30 days since prior experimental drug
排除标准
- 未提供
研究者
研究点 (40)
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