Status:
COMPLETED
Mifepristone (RU-486) in Androgen Independent Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Prostate Cancer
Adenocarcinoma of Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
Detailed Description
Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effe...
Eligibility Criteria
Inclusion
- Histologic documentation of adenocarcinoma of the prostate
- Bone metastasis(es) by bone scan or cat scan
- Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
- One prior chemotherapy treatment is allowed.
- \> 3 weeks since major surgery
- \> 4 weeks since radiotherapy
- \> 8 weeks since prior strontium-89 or samarium 153
- ECOG performance status 0 or 1
- Absolute neutrophil count (ANC) \> 1,500/ul
- Platelets \> 100,000/ul
- Bilirubin \< 1.5 x upper limit of normal (ULN)
- AST or ALT \< 3 x ULN
- Creatinine \< 1.5 x ULN
- Electrolytes within 10% of normal range
- Serum testosterone \< 50ng/dL
- Prostate-specific antigen (PSA) \> 5.0ng/ml
Exclusion
- Concomitant therapy with corticosteroids
- Chemotherapy within 28 days
- Currently active second malignancy other than non-melanoma skin cancer
- Baseline adrenal insufficiency requiring long-term steroids
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00140478
Start Date
February 1 2005
End Date
January 1 2008
Last Update
December 9 2009
Active Locations (4)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20057
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115