Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer
Brief 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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity as measured by CTC v3.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | — |
| Prostate-specific antigen (PSA) at baseline and on day 1 of each course | — |
Countries
United States