NCT00103337已完成2 期
Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Asymptomatic Patients With Metastatic Androgen Independent Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Clinical progression by bone scan or CT scan
研究概览
简要总结
This randomized phase II trial is studying how well cilengitide works in treating patients with metastatic 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 evaluate the efficacy, as measured by the rates of clinical progression at six-months, of two dose levels of EMD121974 in patients with asymptomatic metastatic androgen-independent prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate the safety of the two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer.
II. To assess the objective response rate of two dose levels of EMD121974 in patients with metastatic androgen-independent prostate cancer and bidimensionally measurable disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Metastatic disease that has progressed despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide); patients must demonstrate progression based on at least one of the following criteria:
- •Rising PSA - Defined as by one of the following criteria:
- •Three consecutive rising levels, with an interval of at least 2 weeks between each determination; the last determination must have a minimum value of >= 5 ng/ml and be determined within two weeks prior to registration
- •A PSA value of >= 20 ng/ml obtained within the 12 months prior to randomization and confirmed within 2 weeks prior to registration
- •A 50% rise in PSA values within 6 months prior to registration and confirmed within 2 weeks prior to registration; the last determination must have a minimum value of >= 5 ng/ml
- •Progression of bidimensionally measurable soft tissue (nodal metastasis) assessed within 28 days prior to registration by a CT scan or MRI of the abdomen and pelvis
- •Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan within 42 days prior to registration
- •ECOG performance status of 0-2
- •Minimum PSA >= 5 ng/mL determined within 14 days of registration
- •Testosterone < 50 ng/dL; patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy
- •Patients must have no prostate cancer-related pain, and no visceral metastasis (lung and/or liver)
- •No prior chemotherapy for metastatic disease; no more than one prior non-cytotoxic therapy for metastatic disease
- •No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy; four weeks must have elapsed since major surgery
- •Prior radiotherapy is allowed as long as the bone marrow function is adequate
- •Life expectancy of greater than 6 months
- •WBC >= 3,000/µl
- •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
- •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 document that is approved by the Institutional Human Investigation Committee (HIC)
排除标准
- •Patients may not be receiving any other investigational agents
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •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 tumor 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 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
Arm I (500 mg cilengitide)
Experimental
Patients receive lower dose cilengitide IV over 1 hour twice a week for 6 weeks.
干预措施: cilengitide (Drug)
Arm I (500 mg cilengitide)
Experimental
Patients receive lower dose cilengitide IV over 1 hour twice a week for 6 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm II (2000 mg cilengitide)
Experimental
Patients receive higher dose cilengitide IV over 1 hour twice a week for 6 weeks.
干预措施: cilengitide (Drug)
Arm II (2000 mg cilengitide)
Experimental
Patients receive higher dose cilengitide IV over 1 hour twice a week for 6 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Clinical progression by bone scan or CT scan
时间窗: 6 months
次要结局
- Objective response using RECIST(Up to 30 days post-treatment)
- PSA response based on recommendations from the PSA Working Group(Up to 30 days post-treatment)
- Time to clinical response(Up to 30 days post-treatment)
- Time to PSA response(Up to 30 days post-treatment)
- Incidence of toxicity as assessed by CTCAE v3.0(Up to 30 days post-treatment)
研究者
研究点 (1)
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