Prostate Cancer Clinical Trial
Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
Summary
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.
Full Description
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.
OUTLINE: This is a dose-escalation study.
Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility Criteria
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)
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There is 1 Location for this study
San Francisco California, 94115, United States
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