A Phase II Trial of Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising PSA After Local Therapy
- Each treatment cycle lasts three weeks. During the first three months, participants
will receive the Avastin and docetaxel on day 1 of each three-week cycle for a total of
four doses of docetaxel/Avastin. Avastin and docetaxel are administered intravenously.
The Avastin will continue to be given every three weeks after the docetaxel is
completed for a total of 17 doses (one year) of Avastin therapy.
- Participants will receive zoladex (or lupron) on day 1 of the first cycle and then
every 3 months for a total of 18 months. Zoladex is administered subcutaneously and
Lupron is administered intramuscularly.
- Bicalutamide pills will be started at the completion of docetaxel chemotherapy (start
of month 4) and will be taken once daily until hormone therapy is completed (total of
- During all treatment cycles, the participant will have a physical exam and will be
asked questions about their general health and specific questions about any problems
they might be experiencing. Blood work will be performed every three weeks for the
first three months and then every three months while on hormone therapy and during
- After the final treatment participants will have a follow-up visit every three months
for the first two years, every 4 months for the third year and every 6 months for years
4 and 5.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the proportion of patients free from PSA progression at one year off ADT.
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|University of Maryland - Greenebaum Cancer Center||Baltimore, Maryland 21201|