NCT00031616Unknown1 期
A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers
NewBiotics4 个研究点 分布在 1 个国家开始时间: 2001年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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.
PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of NB1011 in patients with fluoropyrimidine-resistant metastatic or recurrent colorectal cancer.
- Determine the safety and toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug in these patients.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive NB1011 IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of NB1011 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 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 or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma that has progressed during or within 6 months of fluoropyrimidine-based therapy
- •Prior treatment with irinotecan with or without fluorouracil
- •Evaluable or measurable disease
- •Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal
- •No meningeal or CNS metastases or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 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
- •Bilirubin less than 1.5 mg/dL (regardless of liver metastases)
- •AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)
- •PT and INR normal
- •PTT normal
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No known hypersensitivity to NB1011 or any excipient or vehicle in its formulation
- •No active or uncontrolled serious bacterial, viral, fungal, or parasitic infection
- •No prior or concurrent alcohol abuse or dependency
- •No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No concurrent medical or psychological condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Recovered from prior anticancer chemotherapy
- •No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Recovered from prior anticancer radiotherapy
- •No concurrent radiotherapy except palliative radiotherapy (to control a fracture or pain) provided index lesions are not involved
- •Recovered from prior anticancer surgery
- •At least 30 days since prior investigational agents
- •No other concurrent anticancer therapy
- •No concurrent disulfiram
排除标准
- 未提供
研究者
研究点 (4)
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