A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Response rate (RR) defined as is either a complete or a partial response using RECIST criteria
研究概览
简要总结
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery
详细描述
PRIMARY OBJECTIVES:
I. Determine the efficacy of sorafenib, in terms of anti-tumor effects and proportion of clinical responses, in patients with previously untreated unresectable stage III or stage IV melanoma.
SECONDARY OBJECTIVES:
I. Correlate the efficacy of this drug with the presence of mutant or wild-type BRAF gene in tumors of these patients.
II. Determine the toxicity profile of this drug in these patients. III. Correlate serum cryptic collagen epitopes with the extent of tumor burden, invasion, and metastasis in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Histologically or cytologically confirmed unresectable melanoma
- •Stage III or IV disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- •Disease amenable to biopsy (first 13 patients in each stratum only)
- •Brain metastases allowed provided the following criteria are met:
- •Disease has remained radiologically stable for ≥ 6 weeks after completion of whole-brain radiotherapy and remains stable at the time of study entry
- •No mass effect present by radiology
- •No requirement for steroid therapy to control symptoms of brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •At least 3 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No evidence of bleeding diathesis
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No uncontrolled hypertension
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric illness that would preclude study compliance
- •No pre-existing non-hematological dysfunction ≥ grade 2
- •No ongoing or active infection
- •No history of serious allergic reaction to eggs
- •Able to swallow pills
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or other non-invasive carcinoma
- •No other uncontrolled illness
- •Not specified
- •No prior systemic chemotherapy for metastatic disease
- •See Disease Characteristics
- •See Disease Characteristics
- •No other concurrent investigational agents
- •No concurrent therapeutic anticoagulation
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: sorafenib tosylate (Drug)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate (RR) defined as is either a complete or a partial response using RECIST criteria
时间窗: 56 days
The overall response rate along with subgroup-specific response rates will be estimated at the end of the trial along with 95% confidence interval.
次要结局
- Toxicity assessed using NCI CTCAE version 3.0(Up to 3.5 years)
- Time to progression(From the first day of treatment until the first documentation of disease progression, assessed up to 3.5 years)
- Changes in BRAF, P-MAPK, CDK4, and cyclin D1 levels(Baseline and up to 3.5 years)
- Overall survival(Up to 3.5 years)