Satraplatin and Prednisone to Treat Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer, Genetic Polymorphism

In brief

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....

Key facts

Study ID

NCT00634647

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2008-02-19

Expected to finish

2012-05-01

Last updated by the study team

2018-10-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• A. Patients who have had prior treatment with satraplatin or other platinum containing compounds will be excluded.
• B. Patients may not be receiving any other investigational agents.
• C. Patients with known active brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• D. History of allergic reactions attributed to compounds of similar chemical or biologic composition to satraplatin or prednisone.
• E. Uncontrolled intercurrent illness including, but not limited to ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit patient compliance with study requirements.
• F. Prior radiation therapy to greater than 30 percent of the bone marrow, or who have received strontium-89, rhenium-186, or rhenium-188 will be excluded from this trial. Patients who have received prior radiotherapy must have recovered from acute toxicity due to radiation. Patients who have received samarium-153 are eligible for the study because samarium has a significantly reduced half-life compared to aforementioned isotopes.
• G. Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, human immunodeficiency virus (HIV)-positive patients are excluded from the study.
• H. Patients with a history of major gastrointestinal surgery or pathology likely to influence absorption of oral medications, like bypass surgeries, Whipple's procedure, or any surgery that would impair reliable absorption of oral drugs.
• I. Patients with a disease where corticosteroids are contraindicated, e.g. active gastric or duodenal ulcer, or poorly controlled insulin dependent diabetes. Patients with well-controlled insulin-dependent diabetes mellitus may be considered, providing they understand their glucose levels will increase, and their insulin dose will require adjusting.
• J. Because no dosing or adverse event data are currently available on the use of satraplatin in patients less than 18 years of age, children are excluded from this study.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Associates in Oncology and Hematology — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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