NCT00313534终止1 期
A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity as measured by CTC v3.0
研究概览
简要总结
RATIONALE: Nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients with nonmetastatic, biochemically relapsed prostate cancer.
Secondary
- Determine prostate-specific antigen-modulating effects of NDGA in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 prostate cancer, meeting 1 of the following criteria:
- •Androgen-dependent disease (testosterone ≥ 250 ng/mL)
- •Androgen-independent disease (testosterone < 50 ng/mL)
- •Received prior definitive therapy for primary prostate cancer comprising any of the following:
- •External-beam radiotherapy with or without hormonal therapy
- •Brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy
- •Radical prostatectomy with or without adjuvant or salvage radiotherapy
- •Cryotherapy
- •Must have evidence of disease progression, as evidenced by elevated prostate-specific antigen (PSA) that has risen serially from post-definitive therapy nadir on 2 determinations taken ≥ 1 week apart
- •Elevated PSA, meeting 1 of the following criteria:
- •At least 1.0 ng/mL post radiotherapy or cryotherapy
- •At least 4 ng/mL post radical prostatectomy
- •Must show disease progression after discontinuation of the antiandrogen (for patients with androgen-dependent disease receiving antiandrogen as part of primary androgen ablation)
- •No metastatic disease, confirmed by negative bone scan and negative CT scan or MRI of abdomen/pelvis
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Absolute neutrophil count ≥ 1,500/mm³
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •AST ≤ 1.5 times ULN
- •No other medical condition that would interfere with study therapy or compliance
- •No other active malignancy except previously treated squamous cell or basal cell skin cancer or cancer that has been treated and considered to be at < 30% risk of relapse
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 8 weeks since prior strontium-chloride Sr 89
- •More than 4 weeks since first dose of bisphosphonates
- •More than 4 weeks since prior major surgery or radiotherapy
- •At least 4 weeks since prior hormonal agents, including megestrol or steroids
- •Concurrent luteinizing hormone-releasing hormone analogs allowed to maintain castrate levels of testosterone
- •At least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any herbal agent intended to lower PSA
- •Prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for androgen-dependent prostate cancer provided that all of the following are met:
- •No more than 8 months of androgen deprivation
- •At least 12 months since last day of effective androgen deprivation
- •Testosterone > 250 ng/mL at enrollment
- •Prior hormonal therapy, chemotherapy, or investigational therapy for biochemical relapse allowed
- •No concurrent chemotherapeutic, immunotherapeutic, or other investigational agents
- •No concurrent radiotherapy
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity as measured by CTC v3.0
次要结局
- Maximum tolerated dose
- Prostate-specific antigen (PSA) at baseline and on day 1 of each course
研究者
研究点 (2)
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