Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2004-03-31
2006-01-31
Brief Summary
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Detailed Description
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* Patients will complete a daily drug log recording the date, time and number of capsules taken.
* Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
* While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
* Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
* Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Trilostane
Taken orally once a day for three days then twice daily thereafter.
Hydrocortisone
Taken orally with trilostane.
Eligibility Criteria
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Inclusion Criteria
* Disease progression despite androgen depravation therapy and antiandrogen withdrawal
* Progressive measurable disease or bone scan progression or PSA progression
* Serum total testosterone \< 50ng/ml
* Creatinine \< 2.0 mg/dl
* ALT \< 2 x ULN
* CALGB performance status of 0,1, or 2
Exclusion Criteria
* Antiandrogen within 8 weeks
* Other secondary hormonal therapy or investigational agents within 4 weeks
* Prior chemotherapy for androgen-independent prostate cancer
* History of adrenal insufficiency
* Known brain metastases
* Severe liver or renal disease
18 Years
MALE
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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04-037
Identifier Type: -
Identifier Source: org_study_id