Phase II Evaluation of EMD 121974 (NSC 707544, Cilengitide) 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
- 16
- 试验地点
- 1
- 主要终点
- The Number of Patients With a PSA Decline of ≥50%
研究概览
简要总结
This phase II trial is studying how well cilengitide works in treating patients with prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor
详细描述
PRIMARY OBJECTIVES:
I. To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate the safety of EMD121974 in patients with non-metastatic androgen-independent prostate cancer.
II. To assess the change in the slope of Prostate Specific Antigen associated with EMD121974 in patients with non-metastatic androgen-independent prostate cancer.
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
- •A histologic or cytologic diagnosis of prostate cancer
- •No evidence of metastatic disease, or local progression
- •PSA-only progression despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide); PSA progression is defined as 3 consecutive rising levels, with an interval of > 1 week between each determination; the last determination must have a minimum value of >= 2 ng/ml and be determined within two weeks prior to registration
- •If the third confirmatory value is less than the previous value, the patient will still be eligible if a repeat value (No. 4) is found to be greater than the second value
- •Patients must continue on LHRH agonists; they also may continue on any stable doses (considered stable, if on current medicine dosing for one month or longer) of megace or corticosteroids; they must be off all other therapies intended to treat the cancer for 4 weeks
- •ECOG performance status of 0-2
- •No prior EMD 121974 therapy is allowed
- •No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
- •Testosterone < 50 ng/dl; patients must continue primary androgen deprivation with an LHRH agonist, if they have not undergone orchiectomy
- •Four weeks must have elapsed since major surgery
- •Life expectancy of greater than 6 months
- •Patients must have normal organ and marrow function as defined below obtained within 14 days prior to registration:
- •ANC >= 1,500/µl
- •Platelet count >= 100,000/ µl
- •Creatinine =< 1.5 x upper limits of normal
- •Bilirubin within normal limits
- •SGOT (AST) =< 2.5 x upper limits of normal
- •SGPT (ALT) =< 2.5 x upper limits of normal
- •PSA >= 2 ng/ml
- •The effects of EMD 121974 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because antiangiogenic agents are known to be teratogenic, men must agree to use adequate contraception prior to study entry and for the duration of study participation
- •Ability to understand and the willingness to sign a written informed consent that is approved by the Institutional Human Investigation Committee
排除标准
- •Patients may continue on a daily Multi-Vitamin, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration
- •Patients on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy, that show subsequent PSA progression, may continue on this medication, however patients are not allowed to initiate bisphosphonate therapy immediately prior or during the study
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with a "currently active" second malignancy, other than non-melanoma skin cancers or superficial bladder cancer, are not eligible; patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered without evidence of disease for 2 years
研究组 & 干预措施
Experimental treatment: cilengitide
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
干预措施: cilengitide (Drug)
结局指标
主要结局
The Number of Patients With a PSA Decline of ≥50%
时间窗: Up to 5 years
To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. This measure defined as a drop in PSA of at least 50% from the final pre-treatment value.
次要结局
- Median PSA Slope Difference(Baseline to 6 months)
- Median Survival Time(Up to 5 years)
- Mean Time to Progression of Prostate Cancer(Up to 5 years)
- The Number of Participants With at Least One Incident of Toxicity(Up to 5 years)