Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT02873195
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Carcinoma
  • Recurrent Colorectal Carcinoma
  • Refractory Colorectal Carcinoma
  • 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

  • Atezolizumab — DRUG
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Capecitabine — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Placebo — OTHER
    Given IV

Study Details

This randomized phase II trial studies how well capecitabine and bevacizumab with or without atezolizumab work in treating patients with colorectal cancer that is not responding to treatment and has spread to other places. Immunotherapy with monoclonal antibodies, such as atezolizumab 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. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in treating colorectal cancer.

Key Dates

Start date
Jul 7, 2017
Status verified
Jul 2024
Primary completion
Mar 6, 2023
Completion
Dec 1, 2023

Study Design

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

Arms

  • Experimental: Arm I (atezolizumab, bevacizumab, capecitabine)
    Patients receive atezolizumab IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (placebo, bevacizumab, capecitabine)
    Patients receive placebo IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to first documentation of disease progression by RECIST v1.1, or death from any cause, assessed up to 20 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55905-
Roswell Park Cancer InstituteBuffaloNew York14263-
Duke University Medical CenterDurhamNorth Carolina27710-
Rhode Island HospitalProvidenceRhode Island02903-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZMayo Clinic in Arizona· Scottsdale, AZCity of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAEmory University Hospital/Winship Cancer Institute· Atlanta, GAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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