Satraplatin and Prednisone to Treat Prostate Cancer
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Background:
Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer.
Prednisone is approved for treating prostate cancer.
The gene excision repair cross-complementing rodent repair deficiency complementation group 1
(ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have
a variant of this gene will not benefit from treatment with satraplatin because the drug will
not be able to damage the cancer cells effectively.
Objectives:
To determine if satraplatin may help treat prostate cancer in patients with certain variants
of the ERCC1 gene.
Eligibility:
Patients with advanced androgen-independent prostate cancer whose disease has not responded
to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other
tests have shown their cancer to be spreading.
Design:
Participants have a blood test to determine if they have a variant of the ERCC1 gene.
Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days
and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or
longer, depending on the benefits and side effects of the treatment.
During the treatment period, patients undergo the following tests and procedures:
- Blood tests on days 1 of the treatment cycle.
- Weekly blood draws for the first 3 treatment cycles.
- Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to
determine the response to treatment.
- Surgical or medical suppression of testosterone in patients whose cancer cells continue
to grow due to exposure to the hormone....