Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy.
Adenocarcinoma of the Prostate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy|
- Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy [ Time Frame: after 6 months of neoadjuvant chemotherapy. ] [ Designated as safety issue: No ]A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.
- PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy. [ Time Frame: after 6 months of ajuvant chemotherapy. ] [ Designated as safety issue: No ]The rate of PSA decline by 50% compared to baseline PSA.
|Study Start Date:||June 2006|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
docetaxel and bevacizumab prior to prostatectomy
Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.
Other Name: AvastinDrug: Docetaxel
Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.
Other Name: Taxotere
- Patients who are eligible for this study will undergo an endorectal MRI scan test before beginning the research study.
- After the MRI, the patient will begin the docetaxel plus bevacizumab part of the study. Each treatment cycle starts on the day you receive both drugs and lasts 21 days. Patients will undergo a total of 6 cycles-5 with docetaxel plus bevacizumab and one with docetaxel alone.
- At the beginning of each cycle, the patient will come into the clinic for a visit that will last about 3 hours. The following will happen at these visits: physical examination including vital signs and rectal exam; questions about the patients health and the medications they are taking; blood tests (both routine and research blood tests); urine tests; bevacizumab infusion; docetaxel infusion.
- The patients first dose of bevacizumab will be given on Day 1 of the first cycle over 90 minutes. If the patient tolerates the 90-minute infusion well, later doses may be given over a shorter period of time.
- The day before and the morning of the beginning of each cycle, the patient will be given a steroid called dexamethasone in pill form to help decrease the side effects of the treatment.
- The above tests and procedures will be repeated every 21 days a total of five times. For the sixth time, the patient will have all the same tests and procedures except they will not receive bevacizumab.
- After the six cycles, the patient will undergo another endorectal MRI.
- One to two months after finishing the sixth cycle, the patient will undergo a radical prostatectomy to remove their prostate.
- Two to three months after the surgery the patient will return to the clinic to have the following tests and procedures: questions about the patient's health; routine blood tests and research blood tests.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321646
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Mary-Ellen Taplin, MD||Dana-Farber Cancer Institute|