NCT00563823已完成2 期
A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Response rate as assessed by RECIST every 8 weeks
研究概览
简要总结
RATIONALE: Vatalanib 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.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.
Secondary
- To determine the time to progression in these patients.
- To determine the 6-month and 1-year survival of these patients.
- To determine the overall survival of these patients.
- To determine the safety and toxicity of this drug in these patients.
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 metastatic cutaneous melanoma
- •Unresectable disease
- •Measurable disease, defined as ≥ 1 bidimensionally measurable lesion by clinical or radiological techniques (i.e., chest x-ray, CT scan, or conventional MRI scan) using RECIST criteria
- •No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 10 g/dL
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,000/mm^3
- •ANC ≥ 1,500/mm^3
- •Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present)
- •Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present)
- •Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- •Total urinary protein ≤ 500 mg by 24-hour urine collection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry
- •No medical or psychiatric condition that precludes giving informed consent
- •No history of renal disease (e.g., glomerulonephritis) or renal vascular disease
- •No acute or chronic active liver disease (e.g., hepatitis or cirrhosis)
- •No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following:
- •Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- •Unstable angina pectoris
- •Symptomatic congestive heart failure
- •Myocardial infarction within the past 6 months
- •Serious uncontrolled cardiac arrhythmia
- •Uncontrolled diabetes
- •Active or uncontrolled infection
- •No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions:
- •Ulcerative disease
- •Uncontrolled nausea
- •Diarrhea which might result in malabsorption
- •Any known malabsorption syndrome
- •Bowel obstruction
- •Inability to swallow the capsules/tablets
- •PRIOR CONCURRENT THERAPY:
- •Recovered from all prior therapy
- •Prior adjuvant therapy allowed
- •Prior radiotherapy allowed
- •Measurable target lesions must not have been irradiated
- •No more than one line of prior systemic therapy for advanced melanoma
- •More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent
- •More than 2 weeks since prior surgery
- •No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system
- •Concurrent heparin allowed
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate as assessed by RECIST every 8 weeks
次要结局
- Time to progression
- Survival at 6 months and 1 year
- Overall survival
- Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks
研究者
研究点 (2)
Loading locations...
相似试验
撤回
2 期
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine TumorsGastrointestinal Carcinoid TumorIslet Cell CarcinomaNCT00227773Eastern Cooperative Oncology Group
已完成
2 期
Vatalanib in Treating Patients With Recurrent or Progressive MeningiomaBrain and Central Nervous System TumorsSarcomaNCT00348790Northwestern University25
已完成
1 期
Veliparib and Temozolomide in Treating Patients With Recurrent GlioblastomaBrain and Central Nervous System TumorsNCT01026493Radiation Therapy Oncology Group257
已完成
1 期
Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid TumorsUnspecified Childhood Solid Tumor, Protocol SpecificBrain and Central Nervous System TumorsChildhood Germ Cell TumorKidney CancerNeuroblastomaOvarian CancerSarcomaLiver CancerNCT00303940National Institutes of Health Clinical Center (CC)26
已完成
2 期
Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic CancerPancreatic CancerNCT00964171Institut Bergonié19