Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00658697
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
  • Bevacizumab — DRUG
    Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
  • ADT — DRUG
    Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
  • Bicalutamide — DRUG
    Starting on day 84 orally once daily until hormone therapy is completed

Study Details

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)

Key Dates

First listed
Apr 15, 2008
Start date
Jun 30, 2008
Status verified
Apr 2017
Primary completion
Sep 30, 2014
Completion
Jun 30, 2015

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel, Bevacizumab, and ADT
    Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)

Primary Outcome Measure

Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT) [ Time Frame: participants were followed for the duration of the study, an average of 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Maryland - Greenebaum Cancer CenterBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Maryland - Greenebaum Cancer Center· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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