Status:
TERMINATED
Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Insmed Incorporated
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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.
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 singl...
Eligibility Criteria
Inclusion
- Rising prostate-specific antigen (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:
- External beam radiotherapy with or without hormone therapy
- Brachytherapy with or without pelvic external beam radiation or hormone therapy
- 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:
- \> 6 months since last day of effective androgen deprivation
- Testosterone \> 250 ng/dL
- Patient is not on intermittent androgen deprivation
- Karnofsky performance status (KPS) of \> 70%
- Liver Function Tests are within normal range
- Glycated hemoglobin (HgA1c) \< 6%
- Patients must be four weeks from major surgery or radiotherapy to be eligible
Exclusion
- 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 Luteinizing hormone-releasing hormone (LHRH)-agonist or orchiectomy)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00678015
Start Date
May 1 2008
End Date
June 1 2011
Last Update
April 9 2014
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115