A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk
of relapse in patients with prostate cancer who have had their prostate removed by surgery,
but are at high risk of their cancer recurring. During the trial, doctors will also closely
monitor patients for side effects of the chemotherapy.
Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop
growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it
can help shrink tumors in some patients with prostate cancer that has spread to other parts
of their bodies. The researchers conducting this study want to determine if docetaxel also
helps reduce the likelihood of prostate cancer returning after surgery has removed the
original tumor.
All of the study participants will receive up to 18 doses of docetaxel, each administered
through a needle inserted into a vein. Each round of treatment will consist of 30-minute,
weekly infusions for three consecutive weeks, followed by one week with no chemotherapy.
Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that
reduces the risk of an allergic reaction to the medication. If the side effects of the
treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the
trial.