A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
研究概览
简要总结
The purpose of this study is to see if Premarin is useful against androgen-independent prostate cancer and to help understand how drugs such as Premarin may work.
详细描述
Patients will be randomly assigned to one of two study groups (arm A or Arm B). Arm A will receive 1.25mg of Premarin once daily and arm B will receive 1.25mg of Premarin three times a day. Patients will also receive coumadin daily to help prevent thromboembolic disease.
After reviewing the first 30 patients on Arm A, it was determined that arm A (low dose Premarin) was not effective. Arm A was then closed and patients on Arm A were given the choice to switch to Arm B.
Treatment will continue until there is evidence of disease progression or unacceptable side effects.
Every 4 weeks while receiving Premarin, a physical exam and blood work will be performed. Every 12 weeks a CT scan of the abdomen and pelvis and a bone scan will be performed.
Patients will also be encouraged to undergo standard preventative breast irradiation prior to starting Premarin or up to 4 weeks after starting treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Documented histologic evidence of prostate cancer.
- •Progressive androgen-independent prostate cancer as defined by the Prostate-Specific Antigen (PSA) Working Group after conventional androgen deprivation and antiandrogen withdrawal.
- •PSA > 2ng/ml and serum testosterone of < 50ng/ml
- •No history of thromboembolic disease within the prior year
- •ECOG performance status of 0-2
- •Creatinine < 2 x upper limit of normal
- •Bilirubin < 2 x upper limit of normal
- •AST < 2 x upper limit of normal
排除标准
- •Unstable angina or change in anginal symptoms within the past 6 months.
- •Prior therapy with estrogens or PC-SPECS.
- •Concurrent megestrol acetate or steroid hormones
- •Major surgery or radiation therapy within 4 weeks
- •Strontium-89 or samarium-153 therapy within 8 weeks
研究组 & 干预措施
Group A
Premarin once a day
干预措施: Premarin (Drug)
Group B
Premarin 3 times a day
干预措施: Premarin (Drug)
结局指标
主要结局
To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
次要结局
- To evaluate the safety of Premarin in this patient population(2 years)