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Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer
This study is currently recruiting participants.
Verified by University of California, San Francisco, May 2008
Sponsors and Collaborators: University of California, San Francisco
Insmed
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00678015
  Purpose

This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA administration and assessing the proportion of patients who experience a 50% decline in PSA.


Condition Intervention Phase
Prostate Cancer
Drug: Nordihydroguaiaretic Acid (NDGA)
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Masoprocol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non-Metastatic Recurrent Prostate Cancer

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • PSA Response [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Nordihydroguaiaretic Acid (NDGA)
NDGA 2000mg daily

Detailed Description:

This study is a phase II trial of NDGA in patients with hormone-sensitive non-metastatic prostate cancer with a pharmacokinetics component. The first six patients enrolled will be treated with a single 750 mg dose of oral NDGA on day -7 with measurement of pharmacokinetic parameters over eight hours after the dose, then begin treatment with 2000 mg of oral NDGA daily. Every four weeks, measurement of pharmacokinetic parameters at steady state will be done for all patients. All patients will continue dosing with NDGA and will be followed for PSA response and for safety. Measurement of pharmacokinetics for a 750 mg dose has been chosen to evaluate levels with the dosage that patients will be taking at one time point during the day (this is roughly one-third of the daily dose, which is administered in three divided doses).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rising PSA value after local therapy with a PSA doubling time (PSADT) between 6 and 24 months (four or more readings at least two weeks apart within the last six months)
  • Prior definitive therapy for prostate cancer consisting of one of the following:

    1. External beam radiotherapy with or without hormone therapy
    2. Brachytherapy with or without pelvic external beam radiation or hormone therapy
    3. Radical prostatectomy with or without adjuvant or salvage radiation therapy
  • PSA > 1 ng/ml, which has risen serially on two determinations at least one week apart
  • Progressive disease by "Phoenix" consensus definition for patients who have undergone primary radiation therapy (PSA nadir + 2 ng/mL)
  • No metastatic disease
  • Prior adjuvant or neoadjuvant androgen deprivation is permitted, provided:

    1. > 6 months since last day of effective androgen deprivation
    2. Testosterone > 250 ng/dL
    3. Patient is not on intermittent androgen deprivation
  • Karnofsky performance status (KPS) of > 70%
  • Liver Function Tests are within normal range
  • HgA1c < 6%
  • Patients must be four weeks from major surgery or radiotherapy to be eligible

Exclusion Criteria:

  • Presence of another active malignancy other than prostate cancer, or treated squamous/basal cell carcinoma of the skin. Concomitant medical condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements
  • Diabetes mellitus, unless diet-controlled
  • Must be off saw palmetto, pomegranate juice, finasteride, or any herbal agent intended to lower PSA for > 4 weeks. Baseline PSADT calculation must occur off of these agents
  • Patients may not have evidence of local-only recurrence of prostate cancer
  • No history of liver disease, including Hepatitis B or C, alcoholic liver disease, or autoimmune liver disease. A prior history of Hepatitis A is allowed provided that baseline liver function tests are within normal limits
  • Patients with castration resistant prostate cancer are ineligible (prostate cancer which has progressed on androgen deprivation therapy with a LHRH agonist or orchiectomy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678015

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Jay Trovato, RN     415-353-9268     jay.trovato@ucsfmedctr.org    
Contact: Paula Dutton, BS     415-885-7871     walshp@medicine.ucsf.edu    
Principal Investigator: Charles Ryan, MD            
Sponsors and Collaborators
University of California, San Francisco
Insmed
  More Information

Responsible Party: University of California, San Francisco ( Charles Ryan, MD, Principal Investigator )
Study ID Numbers: 075511
Study First Received: May 12, 2008
Last Updated: May 14, 2008
ClinicalTrials.gov Identifier: NCT00678015  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
NDGA
Prostate Cancer

Study placed in the following topic categories:
Nordihydroguaiaretic Acid
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Protective Agents
Lipoxygenase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009