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