Prostate Cancer Clinical Trial

Trilostane for Androgen-Independent Prostate Cancer

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.

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Full 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.
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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00181597

Recruitment Status:

Completed

Sponsor:

Genzyme, a Sanofi Company

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There are 2 Locations for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00181597

Recruitment Status:

Completed

Sponsor:


Genzyme, a Sanofi Company

How clear is this clinincal trial information?

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