Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT02292758
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Adenocarcinoma
  • RAS Wild Type
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Cetuximab — BIOLOGICAL
    Given IV
  • Irinotecan — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Placebo — OTHER
    Given IV

Study Details

This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body (locally advanced/metastatic) and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer.

Key Dates

Start date
Dec 12, 2014
Status verified
Aug 2019
Primary completion
Mar 20, 2019
Completion
Sep 27, 2019

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (cetuximab, bevacizumab, irinotecan)
    Patients receive cetuximab IV over 90-120 minutes, bevacizumab IV over 30-90 minutes, and irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (cetuximab, placebo, irinotecan)
    Patients receive cetuximab IV over 90-120 minutes, placebo IV over 30-90 minutes, and irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Saint Luke's Mountain States Tumor InstituteBoiseIdaho83712-
Siouxland Regional Cancer CenterSioux CityIowa51101-
Cancer Center of Kansas - WichitaWichitaKansas67214-
Ochsner Medical Center JeffersonNew OrleansLouisiana70121-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Michigan Cancer Research Consortium NCORPAnn ArborMichigan48106-
Mayo ClinicRochesterMinnesota55905-
Heartland Regional Medical CenterSaint JosephMissouri64507-
Missouri Baptist Medical CenterSt LouisMissouri63131-
New Hampshire Oncology Hematology PA-HooksettHooksettNew Hampshire03106-
State University of New York Upstate Medical UniversitySyracuseNew York13210-
Saint Vincent Regional Cancer Center CCOPGreen BayWisconsin54301-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZSaint Luke's Mountain States Tumor Institute· Boise, IDSiouxland Regional Cancer Center· Sioux City, IACancer Center of Kansas - Wichita· Wichita, KSOchsner Medical Center Jefferson· New Orleans, LADana-Farber Cancer Institute· Boston, MA

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