NCT00081042已完成2 期
An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 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 ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug.
- Determine the survival of patients treated with this drug.
- Determine the effects of this drug on biomarkers of melanoma in these patients.
- Correlate biomarker levels with response in 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 melanoma
- •Inoperable locally recurrent or metastatic disease
- •Measurable disease
- •No lytic or blastic bone metastasis as only evidence of metastasis
- •Prior radiotherapy to a target lesion allowed provided there has been clear progression of disease since completion of radiotherapy
- •No active brain metastasis, including leptomeningeal involvement
- •Prior brain metastasis allowed provided the disease is in complete remission for at least 1 month after therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •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)
- •Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine ≤ 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception 1 month before and during study participation
- •No pre-existing peripheral neuropathy ≥ grade 2
- •No prior allergy or hypersensitivity to study drug
- •No concurrent clinically significant illness
- •No other concurrent active malignancy
- •No serious medical risk factors involving any of the major organ systems that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Recovered from prior chemotherapy
- •More than 4 weeks since prior cytotoxic chemotherapy
- •At least 3 weeks since prior anthracyclines
- •No concurrent taxane or anthracyclines
- •No concurrent doxorubicin
- •Endocrine therapy
- •No concurrent steroids except as needed for hypersensitivity to study drug
- •Radiotherapy
- •See Disease Characteristics
- •Concurrent radiotherapy to a symptomatic non-target lesion (including recurrent or new brain metastases that develop during study participation) allowed
- •Not specified
- •More than 4 weeks since prior investigational drugs and recovered
- •No other concurrent anticancer therapy
- •No concurrent participation in another clinical study
- •No other concurrent investigational therapies
- •No concurrent ritonavir, saquinavir, indinavir, or nelfinavir
排除标准
- 未提供
研究者
研究点 (1)
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