NCT00077246已完成1 期
An Open-Label, Phase I/II Trial Of ABI-007 (A CREMOPHOR® El-Free, Protein Stabilized, Nanoparticle Paclitaxel) Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) in patients with chemotherapy-naïve stage IV non-small cell lung cancer.
- Determine the antitumor activity of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the time to disease progression in patients treated with this drug.
- Determine duration of response in patients treated with this drug.
- Determine survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 stage IV non-small cell lung cancer
- •Evidence of inoperable local recurrence or metastasis
- •Bone metastases or other nonmeasurable disease may not be only evidence of metastasis
- •Measurable disease documented radiographically
- •No evidence of active brain metastases or leptomeningeal involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-1 OR
- •Karnofsky 80-100%
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin normal
- •Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases)
- •Creatinine ≤ 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception for 1 month before and during study participation
- •No prior allergy or hypersensitivity to study drug
- •No other concurrent active malignancy
- •No pre-existing peripheral neuropathy grade 1 or greater
- •No other concurrent clinically significant illness
- •No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for metastatic disease
- •More than 4 weeks since prior cytotoxic chemotherapy
- •No concurrent doxorubicin
- •No other concurrent taxanes
- •No concurrent anthracyclines
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy to a major bone marrow-containing area
- •More than 4 weeks since prior radiotherapy except to a non-target lesion
- •Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy
- •Not specified
- •Prior epidermal growth factor-targeted therapy allowed
- •More than 4 weeks since prior investigational drugs
- •No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed
- •No concurrent treatment with any of the following:
- •Ritonavir
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
Objective target lesion response (complete or partial) as measured by RECIST criteria
次要结局
- Nadir of myelosuppression
- Changes in physical examination
- Changes in hematologic and clinical chemistry values
- Percentage of patients with complete or partial target response (total response)
- Duration of response
- Incidence of treatment-emergent adverse events and serious adverse events
- Percentage of patients with stable disease for ≥ 16 weeks
- Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
- Time to disease progression
- Survival
研究者
研究点 (1)
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