NCT00811759Unknown1 期
Open-label, Single Center, Uncontrolled Phase I/II Study Evaluating the Safety and Maximum Tolerated Dose of Daily Sorafenib Administered in Combination With Prolonged Temozolomide in Patients With Metastatic Melanoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (Phase I)
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety profile and the maximum tolerated dose of sorafenib tosylate and temozolomide in patients with stage III-IV melanoma. (Phase I)
- Evaluate progression-free survival at 12 weeks. (Phase II)
Secondary
- Evaluate tumor response according to RECIST criteria.
- Evaluate overall and progression-free survival.
- Evaluate the effect of treatment on tumor vascularization.
- Compare the pharmacokinetic profile of temozolomide with and without sorafenib tosylate.
- Evaluate the number and the role of lymphocytes.
- Correlate tumor response rate with BRAF mutation status.
- Correlate response rate with MGMT activity.
- Compare the efficacy of genomics and proteomics as a means of discovery of serum biomarkers.
- Study the prognostic and predictive value of circulating endothelial cells and circulating endothelial progenitors.
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:
- •Diagnosis of unresectable or metastatic melanoma
- •Stage III or IV disease
- •Previously treated or untreated metastatic disease
- •At least one unidimensionally measurable lesion by RECIST criteria by scan or MRI
- •No concurrent brain or CNS metastases
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Life expectancy ≥ 3 months
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin > 9 g/dL
- •PT, INR, and PTT < 1.5 times upper limit of normal (ULN)
- •Transaminases < 2.5 times ULN (< 5 in the case of liver metastases)
- •Amylase and lipase < 1.5 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •Serum creatinine < 1.5 times ULN
- •Normal respiratory, cardiac, and neurological function
- •Not pregnant or nursing
- •No history of any of the following cardiac conditions:
- •NYHA class II-IV heart failure
- •Coronary disease
- •Myocardial infarction within the past 6 months
- •Cardiac arrhythmia requiring treatment with something other than beta-blockers or digoxin
- •Severe uncontrolled hypertension
- •No severe active infection > grade 2
- •No epilepsy requiring medical treatment
- •No other cancer except for carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumors, or curatively treated cancer > 3 years ago
- •No HIV or hepatitis B or C positivity
- •No lactase or galactokinase deficiency, galactose intolerance, or disease accompanied by malabsorption of glucose or galactose
- •No allergy to the study drugs or to dacarbazine
- •Able to swallow medications
- •No patients deprived of liberty
- •No psychological, familial, social, or geographic conditions that would preclude clinical follow up
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior organ transplantation
- •No prior temozolomide or sorafenib tosylate
- •More than 30 days since other prior antitumor chemotherapy, immunotherapy, hormonal therapy, or investigational agent
- •More than 30 days since prior study drugs
- •More than 3 weeks since prior radiotherapy
- •More than 3 weeks since prior biological response modifiers (i.e., filgrastim [G-CSF])
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (Phase I)
Progression-free survival at 12 weeks (Phase II)
次要结局
未报告次要终点
研究者
研究点 (1)
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