Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: masoprocol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: masoprocol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity as measured by CTC v3.0 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  |  | 
| Prostate-specific antigen (PSA) at baseline and on day 1 of each course |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer