Status:
COMPLETED
Trilostane for Androgen-Independent Prostate Cancer
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.
Detailed Description
* Patients will take trilostane orally once a day for three days, then twice a day thereafter. * Patients will complete a daily drug log recording the date, time and number of capsules taken. * Trilos...
Eligibility Criteria
Inclusion
- Histologically confirmed prostate adenocarcinoma
- 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
- Radiation therapy within 4 weeks
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00181597
Start Date
March 1 2004
End Date
January 1 2006
Last Update
December 3 2013
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115