Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Etoposide is a drug that has been shown to interfere with the growth of cancer cells, which
may cause them to eventually die.
Cisplatin has an atom at its center that contains platinum. The platinum is supposed to
poison the cancer cells, which may cause them to eventually die.
If you are found to be eligible to take part in this study, you will receive carboplatin
plus docetaxel by a vein or central line in a vein. You will receive carboplatin over about
30 minutes and docetaxel over about 60 minutes. You will receive this therapy combination
on Day 1 of each cycle of therapy (every 3-4 weeks), depending on the recovery of your bone
marrow. These 3-4 weeks are considered 1 cycle of therapy. This therapy combination will be
given on an outpatient basis. If you experience any side effects, your dose of docetaxel
plus carboplatin may be decreased.
You will be given dexamethasone, by a vein in your arm, by central line in a vein, or by
mouth, before your therapy begins with docetaxel plus carboplatin. Dexamethasone will help
decrease bone marrow inflammation. You will also be given a colony stimulating factor (when
the doctor thinks it is needed) to help maintain your white blood cell count to help
decrease any chance of infection. Colony stimulating factor will be given as a subcutaneous
injection (under the skin), at the discretion of the treating physician, during therapy.
You will have about 2-3 tablespoons of blood drawn at the beginning of each cycle of therapy
for routine blood tests and blood tests for cancer markers. You will be asked about any
medications you are currently taking.
At the end of the first 2 cycles of therapy, you will have some or all of the scans
(performed during the screening visit) repeated to evaluate your disease. If your disease
is responding well to the therapy, you will continue on docetaxel plus carboplatin for 2
more cycles. In this case, you will continue receive the study combination until your doctor
thinks you have received the most benefit. You will then be followed with some or all of
the scans (performed during the screening visit) every 2 months unless your cancer
progresses (gets worse) or until you begin on a new therapy after your treatment has ended
on this study.
If you are already taking hormone therapy with an LHRH agonist (such as Lupron or Zoladex) ,
you will continue taking these medications. If you are taking an anti-androgen drug (such as
Casodex), you should stop taking it.
If your cancer is progressing after having had a maximal response, if your disease does not
respond after 2 courses of therapy, or if you are not able to tolerate some side effects of
docetaxel plus carboplatin, your chemotherapy will be switched to etoposide plus cisplatin.
If this is the case, etoposide plus cisplatin will be given to you by a vein in your arm or
central line in a vein. You will receive this therapy combination once a day (etoposide over
60 minutes and cisplatin over 2 hours) for the first 3 days during each cycle of therapy,
and then therapy will be repeated every 3 to 4 weeks.
Therapy with etoposide plus cisplatin will be continued as long as your cancer responds well
to this therapy and you are not experiencing any intolerable side effects. If you experience
any side effects, your dose of etoposide plus cisplatin may be decreased. This treatment
combination may be given on an inpatient basis.
You will be removed from this study if your disease gets worse or you experience any
intolerable side effects.
If you come off this study because you completed therapy, your disease got worse, or you
experienced intolerable side effects, you will have an end-of-study visit. During this
visit, you will have blood drawn (about 3 tablespoons) for routine tests. You will have a
complete physical exam, including measurement of your vital signs. You will also have your
complete medical history recorded and you will be asked about any medications you are
currently taking. You will have imaging scans to evaluate your disease (similar to those at
screening) if they have not been done in the last 28 days.
Once you are no longer on this study, the research staff will periodically check up on you
(about every 6 months). This update will consist of a phone call, an e-mail, or a review of
your medical and/or other records. No clinic visits or additional diagnostic studies are
required by the study. If contacted by phone, the call would only last a few minutes.
This is an investigational study. Carboplatin, docetaxel, etoposide, and cisplatin are all
commercially available and approved by the FDA. Up to 120 patients will take part in this
multicenter study. Up to 90 will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate and Time to Progression (TTP)
Response evaluated at end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1).
Ana M. Aparicio, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of California-San Francisco||San Francisco, California 94143|
|UT MD Anderson Cancer Center||Houston, Texas 77030|