A Phase 2 interventional study of Taxotere and Prednisone in Prostate Cancer, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-30.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Objectives:
Primary:
Secondary:
The Study Drugs:
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.
Prednisone and docetaxel are commonly used to treat prostate cancer.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1 of every 21-day study "cycle", you will receive docetaxel through a needle in your vein over 1 hour.
Everyday, you will take prednisone by mouth 2 times a day (in the morning and evening). You should take prednisone with meals.
You will take dexamethasone by mouth at 12 hours and 6 hours before you receive docetaxel. This is to help reduce the risk of any allergic reaction and fluid retention. It is important that you take this drug on schedule.
Study Visits:
On Day 1 of each cycle, the following tests and procedures will be performed:
Blood (about 2 teaspoons) will be drawn for routine tests and to test for PSA and testosterone levels.
On Day 1 of Cycle 3, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Surgery:
If you complete 2 cycles or more, you will be eligible to have surgery as part of this study.
If you are eligible, no more than 21 days after your last dose of docetaxel, you will have surgery to remove your prostate gland. You will sign a separate consent for this surgery, which will describe the procedure and its risks in detail.
Before surgery, probably at your pre-surgical visit, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Length of Study:
You will take the study drug for up to 4 cycles before having surgery. You will be off study treatment after you have surgery. You will be taken off study early if you experience intolerable side effects or the disease gets worse.
This is an investigational study. Docetaxel given with prednisone is commercially available and FDA approved for the treatment of prostate cancer.
Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Taxotere · Drug: Prednisone
75 mg/m\^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
Also known as: docetaxel
5 mg twice a day by mouth.
Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR)
Time frame: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model.
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center