NCT00483301已完成2 期
A Phase II Trial OF Carboplatin, ABI-007 (Abraxane) And Sorafenib (BAY 43-9006) in Metastatic Melanoma
Mt. Sinai Medical Center, Miami4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2007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
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Primary Objective
研究概览
简要总结
The purpose of this study is to compare the effects, good and/or bad, of Carboplatin and ABI-007 (Abraxane) in combination with Sorafenib (BAY 43-9006) on Melanoma.
详细描述
The primary objective of this phase II multicenter trial is to:
Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma
The secondary objectives are to:
Assess the safety and toxicity of this regimen in this patient population
Determine the 1-year and median PFS of patients treated according to protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Histologically confirmed diagnosis of melanoma with measurable disease
- •Patients with stage IV, previously untreated, refractory to initial therapy or progressing after response to initial therapy
- •Patients with unresectable stage III, including unresectable in-transit metastases
- •Two prior chemotherapy regimen is allowed
- •One prior immunotherapy regimen is allowed
- •No other concurrent investigational therapy
- •Radiation therapy to non-target lesions or to one of multiple target lesions may be allowed on a case-by-case basis
- •Patients must be past the nadir from previous cytotoxic therapy
- •Age at least 18 years
- •ECOG performance status 0-2
- •Hemoglobin > 9.0 g/dl, absolute neutrophil count (ANC) > 1,500/mm3, platelet count > 100,000/mm3
- •Total bilirubin within normal limits, ALT and AST < 2.0 x the ULN ( < 5 x ULN for patients with liver involvement), INR < 1.5 and aPTT within normal limits. Patients who receive anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care.
- •Creatinine < 1.5 x ULN, serum calcium within normal limits
- •Patients with stable brain metastasis who have been treated with either whole brain radiation or Gamma Knife and have been off steroids for > 4 weeks
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least three months after the last administration of protocol drugs. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- •Ability to understand and sign a written informed consent document. All patients must have a signed informed consent before registration and initiation of therapy
排除标准
- •Cardiac disease: Congestive heart failure > class II NYHA.
- •Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- •No known severe hypersensitivity or suspected allergy to sorafenib, ABI-007 or any of the excipients
- •Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude progressing brain metastasis.
- •Peripheral neuropathy greater than grade II
- •Serious intercurrent medical or psychiatric illness, including serious active infection
- •Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- •Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- •Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- •Serious non-healing wound, ulcer, or bone fracture.
- •Evidence or history of bleeding diathesis or coagulopathy
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- •Use of St. John's Wort or rifampin (rifampicin)
- •Any condition that impairs patient's ability to swallow whole pills.
- •Any malabsorption problem
- •No treatment for melanoma within the previous 4 weeks.
结局指标
主要结局
Primary Objective
时间窗: one - two years
Measure the response rate (RR) of this combination and schedule in patients with metastatic melanoma
次要结局
- Secondary Objective(one-two years)
研究者
Jose Lutzky
Study Principal Investigator
Mt. Sinai Medical Center, Miami
研究点 (4)
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