Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus (BEV/EV)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Expanded Cohort of Patients With Refractory Metastatic Colorectal Cancer (MCRC) Treated With Bevacizumab and Everolimus|
- Overall Response [ Time Frame: Measured 1 month after the last treated subject came off treatment ] [ Designated as safety issue: No ]Overall response is composed of complete responses and partial responses. Complete response (CR): disappearance of all target lesions; Partial response: at least a 30 percent decrease in the sum of the longest diameter of the target lesions taking as reference the baseline sum longest diameter. Response is assessed at each subject's restaging, approximately ever 2 months.
- Progression Free Survival (PFS) [ Time Frame: interval between start of treatment and 8-week ] [ Designated as safety issue: No ]8 week PFS
|Study Start Date:||October 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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
10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle
Other Name: AvastinDrug: Everolimus
10 mg Everolimus(RAD001) daily by mouth, days 1-28
Other Name: RAD001
This open-label, non-randomized expanded cohort trial of bevacizumab and RAD001 for patients with refractory metastatic colorectal cancer is designed to assess preliminary efficacy as well as the safety and tolerability of this combination. Patients will be accrued to this study at Duke University Medical Center and The Duke Oncology Outreach Network (DON)
After satisfying eligibility and screening criteria, patients will be treated on 28 day cycles.
The treatment regimen is as follows:
10 mg/kg Bevacizumab intravenous on days 1 and 15 and 10mg everolimus (RAD001) daily by mouth
- Toxicity will be assessed every visit, and as clinically indicated.
- Efficacy will be assessed every 2 cycles, and as clinically indicated.
- Patients may remain on treatment as long as they are deemed to be clinically benefiting from treatment, do not have progressive disease on restaging imaging (Section 6.0), or do not have any other reason for discontinuation of treatment as outlined in Section 3.4.
- Patients will undergo correlative studies as outlined in the study protocol
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Herbert I Hurwitz, MD||Duke University|