Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Time To Progression (TTP) in Weeks
研究概览
简要总结
The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.
详细描述
This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.
Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA (Prostate-specific Antigen) has doubled from pretreatment baseline.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of prostate cancer
- •No evidence of metastatic disease
- •PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal
- •Patients must maintain castrate levels of testosterone (<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy.
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death)
- •No prior anti-VEGF therapy is allowed
- •No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy
- •Age greater than or equal to 18 years
- •Life expectancy greater than 6 months
- •Normal organ and marrow function obtained within 14 days prior to registration
- •Must use adequate contraception prior to study entry and for the duration of study participation.
排除标准
- •Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration.
- •Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy.
- •Uncontrolled incurrent illness
- •Patients with a "currently active" second malignancy are not eligible.
- •Major surgery less than or equal to 4 weeks prior to randomization
- •Prior chemotherapy less than or equal to 3 weeks prior to registration
- •Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration
- •Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration
- •Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration.
- •Patients must not be on nonsteroidal antiandrogen blockade.
- •Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis.
研究组 & 干预措施
PTK787
PTK787:
250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily
干预措施: PTK787 (Drug)
结局指标
主要结局
Time To Progression (TTP) in Weeks
时间窗: 12 Months
次要结局
- Number of Toxicities in Patients Treated with PTK787(30 Days After Last Dose)
- Overall Survival(12 Months)