Not Signed In -
Androgen insensitivity syndrome |
AIS; AR deficiency; DHTR deficiency; Dihydrotestosterone receptor deficiency; Testicular feminization syndrome; TFM |
Clinical Trial: Mifepristone (RU-486) in Androgen Independent Prostate Cancer
This study is currently recruiting patients.
Verified by Dana-Farber Cancer Institute August 2005
|
Purpose
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Androgen Independent Prostate Cancer Prostate Cancer Adenocarcinoma of Prostate | Drug: Mifepristone (RU-486) | Phase II |
MedlinePlus related topics: Cancer; Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer with Correlative Assessment of Androgen Receptor Co-Repressor Proteins
Further Study Details:
Primary Outcomes: To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer.
Secondary Outcomes: To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer.
Expected Total Enrollment: 48
Secondary Outcomes: To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer.
Expected Total Enrollment: 48
Study start: February 2005
- 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 effects.
- At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.
- After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- 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
- ANC > 1,500/ul
- Platelets > 100,000/ul
- Bilirubin < 1.5 x ULN
- AST or ALT < 3 x ULN
- Creatinine < 1.5 x ULN
- Electrolytes within 10% of normal range
- Serum testosterone < 50ng/dL
- PSA> 5.0ng/ml
Exclusion Criteria:
- 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00140478
Mary-Ellen Taplin, MD 617-632-3466 mary-ellen_taplin@dfci.harvard.edu
Nick Rohs nrohs@partners.org
Nick Rohs nrohs@partners.org
District of Columbia
Georgetown University, Washington, District of Columbia, 20057, United States; Recruiting
Ed Gelmann, MD, Sub-Investigator
Asim Amin, MD, Sub-Investigator
Asim Amin, MD, Sub-Investigator
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Mary-Ellen Taplin, MD, Principal Investigator
Philip Kantoff, MD, Sub-Investigator
William Oh, MD, Sub-Investigator
Leonard Appleman, MD, Sub-Investigator
Robert Ross, MD, Sub-Investigator
Laurie Appleby, NP, Sub-Investigator
Sandra Kelly, NP, Sub-Investigator
Philip Kantoff, MD, Sub-Investigator
William Oh, MD, Sub-Investigator
Leonard Appleman, MD, Sub-Investigator
Robert Ross, MD, Sub-Investigator
Laurie Appleby, NP, Sub-Investigator
Sandra Kelly, NP, Sub-Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States; Recruiting
Glenn Bubley, MD, Principal Investigator
Jennifer Yannucci, MD, Sub-Investigator
Jennifer Yannucci, MD, Sub-Investigator
Massachusetts General Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Matthew Smith, MD, Principal Investigator
Donald Kaufman, MD, Sub-Investigator
Dror Michaelson, MD, Sub-Investigator
Erika Barrett, NP, Sub-Investigator
Donald Kaufman, MD, Sub-Investigator
Dror Michaelson, MD, Sub-Investigator
Erika Barrett, NP, Sub-Investigator
Study chairs or principal investigators
Mary-Ellen Taplin, MD, Principal Investigator, Dana-Farber Cancer Institute
More Information
Study ID Numbers: 04-249
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140478
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140478
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Resources
- Adult erotosexual status and fetal hormonal masculinization and demasculinization: 46, XX congen (Google Health)
- Androgen insensitivity syndrome (Google Health)
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