Trial Information

A Phase II Study of Docetaxel Plus Carboplatin in Hormone Refractory Prostate Cancer Patients Refractory to Prior Docetaxel-based Chemotherapy

Patients will receive both carboplatin and docetaxel. This treatment is given in the
outpatient department once every 3 weeks (called one cycle).

One day prior to the day of chemotherapy, patients are given a steroid drug (dexamethasone)
to be taken twice a day for 3 days. This helps to decrease the risk of an allergic
reaction.

On the day of chemotherapy, both docetaxel and carboplatin will be given through a vein over
two to three hours. Docetaxel will be given before carboplatin. In addition, patients
receive zofran, an anti-vomiting agent, to try to prevent nausea and vomiting. Study
participants are also given a prescription for anti-nausea pills to take at home.

After each cycle of treatment, patients are required to get their bloods checked (between
days 8-12 of the cycle). This may be done at an outside laboratory closer to the patient's
home.

Treatment will be repeated every three weeks provided the blood tests and physical
examination done prior to each treatment are acceptable. If a patient is not able to receive
the next scheduled dose of chemotherapy, the doctor will delay the treatment for a week to a
maximum of two weeks, beyond which, the patient will be taken off the trial. If there is a
delay of more than one week or the study participant has significant side effects, their
doctor will decrease the dose of the carboplatin and docetaxel. During the treatment
period, doctors may also prescribe medications to treat low red blood cells or low white
blood cells.

Before each cycle (every 3 weeks), there will be routine blood tests drawn (about 3
teaspoons) to monitor bone marrow, liver, and kidney functions. These samples will look at
two proteins in the blood and may help us predict who will respond to docetaxel and
carboplatin. We will also obtain CT scans after every 3 cycles of treatment and at the end
of the study. A bone scan will also be done after every 3 cycles if there was evidence of
bone involvement on the first bone scan. A bone scan may also be ordered during the study in
patients without prior evidence of bone involvement if the doctor suspects that the cancer
has now spread to the bone.