Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT01083368
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • temsirolimus — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • polymorphism analysis — GENETIC
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may be a better way to block tumor growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with bevacizumab and to see how well it works in treating patients with hormone-resistant metastatic prostate cancer that did not respond to chemotherapy.

Key Dates

First listed
Mar 9, 2010
Start date
Jan 31, 2009
Status verified
Aug 2019
Primary completion
Dec 31, 2011
Completion
Oct 31, 2014

Study Design

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

Arms

  • Experimental: Arm 1: Combination of temsirolimus and AVASTIN
    Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Temsirolimus (Phase I) [ Time Frame: at 24 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-
CCF-Willoughby HillsWilloughby HillsOhio44094-

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OHCCF-Willoughby Hills· Willoughby Hills, OH

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