Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT00879359
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • carboplatin, paclitaxel, and bevacizumab — DRUG
    All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.

Study Details

The purpose of this study is to find out whether the addition of a drug called Avastin (avastin) to the two-drug combination of carboplatin and paclitaxel shrinks tumors better than the two-drug combination alone in the treatment of endometrial cancer. Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. Avastin is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that feed the tumor cells.

Key Dates

First listed
Apr 10, 2009
Start date
Dec 31, 2007
Status verified
Mar 2017
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

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

Arms

  • Experimental: I

Primary Outcome Measure

Number of Participants With Progression Free Survival (PFS=Date of Progression of Disease or Death) at 6 Months Using Bevacizumab, Carboplatin, and Paclitaxel in Patients With Measurable Disease for Advanced/Recurrent Endometrial Cancer [ Time Frame: 58 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44129-

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