NCT00054015已完成2 期
A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer
Vion Pharmaceuticals4 个研究点 分布在 1 个国家开始时间: 2002年12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
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.
详细描述
OBJECTIVES:
- Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-AP IV over 2 hours on days 1-4. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for up to 1 year.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods:
- •Measurable disease
- •PSA level of at least 5 ng/mL with a positive bone scan
- •Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following:
- •An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart
- •A new symptomatic lesion on bone scan
- •A new metastases not in bone
- •Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient
- •Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure
- •Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study
- •No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment )
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Bilirubin no greater than 2.0 mg/dL
- •ALT/AST no greater than 5 times upper limit of normal
- •Albumin greater than 2.5 g/dL
- •Chronic hepatitis allowed
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 3 months
- •No unstable angina
- •No uncontrolled arrhythmias
- •No uncontrolled congestive heart failure
- •No dyspnea at rest
- •Nutrition adequate (caloric intake considered adequate for maintenance of weight)
- •Fertile patients must use effective contraception
- •No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago
- •No active uncontrolled infectious process
- •No other life-threatening illness
- •No peripheral neuropathy greater than grade 2
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 2 weeks since prior biologic therapy
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •Endocrine therapy
- •See Disease Characteristics
- •At least 4 weeks since other prior hormonal therapy including any of the following:
- •Megestrol
- •Finasteride
- 另有 10 项未显示
排除标准
- 未提供
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Combination Chemotherapy in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00024323Vion Pharmaceuticals
已完成
1 期
3-AP in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00006218Vion Pharmaceuticals
已完成
1 期
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00016874Vion Pharmaceuticals
已完成
1 期
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid LeukemiaDrug/Agent Toxicity by Tissue/OrganLeukemiaNCT00003268Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
终止
2 期
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast CancerBreast CancerNCT00049660European Organisation for Research and Treatment of Cancer - EORTC47