Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Herbert Hurwitz
Study ID
NCT00597506
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle
  • Everolimus — DRUG
    10 mg Everolimus(RAD001) daily by mouth, days 1-28

Study Details

The purpose of this study is to find the safest and most effective dose of the drugs bevacizumab and everolimus given in combination for the treatment of metastatic colorectal cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a vein). Everolimus (also called RAD001) is a tablet that is taken by mouth. Bevacizumab is a protein that is thought to prevent the formation of blood vessels tumors need to grow. RAD001 has multiple capabilities, like bevacizumab it may prevent the formation of blood vessels needed by tumors and it also may stop tumor growth. This study will try to find the safest dose of these drugs that can be tolerated when taken in combination. The study will look at how the drugs work in the body, and will see if there is any effect on metastatic colorectal cancer.

Key Dates

First listed
Jan 18, 2008
Start date
Oct 31, 2007
Status verified
Dec 2012
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab and Everolimus
    10 mg Everolimus(RAD001) daily by mouth, days 1-28 10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle

Primary Outcome Measure

Overall Response [ Time Frame: Measured 1 month after the last treated subject came off treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

Related Studies