Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT00449163
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.

Key Dates

Start date
Mar 1, 2006
Status verified
Apr 2017
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

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

Arms

  • Experimental: Combination Chemotherapy and Bevacizumab
    Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29: * Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22; * Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29; * Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29; * Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.

Primary Outcome Measure

Overall Survival up to 2 Years [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Miami· Miami, FL

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