Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer

Part of paid clinical trials in Beverly Hills, California.

Sponsor
University of Southern California
Study ID
NCT00574769
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • RAD001, Docetaxel, Bevacizumab — DRUG
    RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m\^2 every 21 days

Study Details

Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).

Key Dates

First listed
Dec 17, 2007
Start date
Feb 17, 2010
Status verified
Apr 2017
Primary completion
Feb 17, 2016
Completion
Feb 17, 2017

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab [ Time Frame: After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab ]

Locations (2)

FacilityCityStateZIPSite coordinators
Westside Prostate Cancer Center, University of Southern CaliforniaBeverly HillsCalifornia90211-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Beverly Hills, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Westside Prostate Cancer Center, University of Southern California· Beverly Hills, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CA

Related Studies