NCT00054522已完成2 期
Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.
详细描述
OBJECTIVES:
- Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
- Determine the safety of this regimen in these patients.
- Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.
OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).
Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:
- •Curatively treated with radical prostatectomy OR definitive radiotherapy
- •No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor
- •No local recurrence by CT scan or MRI of the pelvis
- •No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results
- •At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available
- •PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy
- •Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 months
- •Hematopoietic
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •Creatinine less than 1.8 mg/dL
- •Phosphorus normal
- •No hypercalcemia (albumin-corrected calcium greater than ULN)
- •No nephrolithiasis
- •Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study
- •Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
- •No symptomatic pancreatitis
- •No uncontrolled diabetes
- •No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)
- •Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for prostate cancer
- •At least 24 months since prior chemotherapy for other diseases
- •Endocrine therapy
- •More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)
- •No prior androgen deprivation therapy of more than 8 months duration
- •No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy
- •No concurrent androgen therapy
- •Radiotherapy
- •See Disease Characteristics
- •More than 3 months since prior radiotherapy for locally recurrent prostate cancer
- •No concurrent radiotherapy, including for pain control
- •See Disease Characteristics
- •More than 4 weeks since prior investigational drugs
- •No concurrent medication known to affect systemic calcium metabolism, including any of the following:
- •More than 400 IU of cholecalciferol supplements
- •More than 500 IU of vitamin A supplements
- •Calcium supplements
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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