Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer
NCT00658697 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2017-05-25
Summary
In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or radiation)
Conditions
Interventions
- DRUG
-
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
- DRUG
-
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
- DRUG
-
ADT
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
- DRUG
-
Bicalutamide
Starting on day 84 orally once daily until hormone therapy is completed
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Mary-Ellen Taplin, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2014-09-30
- Completion
- 2015-06-30
Countries
- United States
Study Locations
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