- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00313534
Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Dose-limiting toxicity as measured by CTC v3.0
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Secondary Outcome Measures
Outcome Measure |
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Maximum tolerated dose
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Prostate-specific antigen (PSA) at baseline and on day 1 of each course
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Charles Ryan, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Protective Agents
- Antioxidants
- Lipoxygenase Inhibitors
- Masoprocol
Other Study ID Numbers
- CDR0000455645
- UCSF-035510
- UCSF-H45860-23712-02A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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