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Metastatic Colorectal CancerPhase 3NCT00252564

Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer

A Phase 3 study testing Bevacizumab, Oxaliplatin and Leucovorin in people with Metastatic Colorectal Cancer, run by US Oncology Research at 82 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Bevacizumab, Oxaliplatin and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
82 sitesUnited States
Study dates
Sep 2005to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed colorectal cancer with metastatic disease
  • Measurable disease
  • Previously irradiated lesions will be considered evaluable, if they progressed since radiation
  • Has disease other than limited to surgically resectable liver-only or lung-only metastatic disease
  • Not received prior chemo and/or biotherapy for metastatic disease
  • Not received oxaliplatin, bevacizumab, or cetuximab in the adjuvant setting
Show all 15Show fewer
  • May have received 5-FU, leucovorin, and/or irinotecan in the adjuvant setting, however must have remained free of disease recurrence (including free of abnormal CEA level) for 1- year or more
  • Is >18 years of age
  • ECOG performance status 0 or 1
  • Normal organ \& marrow function
  • Use of an acceptable method of birth control
  • Not pregnant or breast feeding
  • Paraffin tissue block(s) or 12 (minimum) unstained slides available, for assessment of potential predictive markers related to the EGFR, VEGF, DNA repair, and fluoropyrimidine catabolism pathways. If no block is available, slides (typically 7 to 10 um sections, air dried on uncharged slides) may be sent
  • Signed a Patient Informed Consent Form
  • Signed a Patient Authorization Form (HIPAA) Form

Who cannot join

  • Had prior chemotherapy for metastatic colorectal cancer
  • Received any prior treatment with oxaliplatin, bevacizumab, or cetuximab in the adjuvant treatment of their colorectal cancer
  • Currently receiving any other investigational anticancer agents or has participated in an experimental drug study within the past 4 weeks
  • History of primary CNS tumors, seizures not well-controlled with standard medical therapy, or stroke
  • Sustained hypertension, as characterized by persistent blood pressures greater than 150/100 despite medical management
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure or has had angioplasty or placement of coronary stents within the past 6 months
Show all 23Show fewer
  • Clinically significant peripheral vascular disease
  • History of serious allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, cetuximab, oxaliplatin, fluorouracil, leucovorin, or other agents used in the study
  • Received prior cetuximab or other EGFR-directed therapy, or history of prior anti-cancer murine or chimeric monoclonal antibody therapy; prior humanized and human monoclonal antibody therapy is also excluded.
  • Received prior treatment with bevacizumab or other agents specifically targeting VEGF or VEGF receptors
  • Uncontrolled intercurrent illness including, not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the Investigator/Treating Physician
  • Serious or non-healing active wound ulcer, or active bone fracture
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of protocol treatment
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
  • Current or recent use of a thrombolytic agent within last 30 days. Use for clearance of central line catheter is permitted.
  • Evidence of bleeding diathesis (disorder) or clinically significant coagulopathy (Note that deep venous thrombosis is not regarded as a reason for exclusion from this trial)
  • Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • History of arterial thromboembolic events within 6 months
  • Urine protein:creatinine ratio greater than 1.0 at screening
  • Pregnant or lactating woman
  • Known to be HIV positive or receiving combination anti-retroviral therapy
  • Unable to comply with study requirements

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

United States82 sites

  • Texas Cancer Center-Abilene (Shouth)

    Abilene, Texas, 79606

  • Cancer Center Associates of Carolina, PA / fka Carolina Cancer Center

    Aiken, South Carolina, 29801

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Medical Oncology Associates of Augusta PC

    Augusta, Georgia, 30901

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Auerbach Hematology Oncology Associated

    Baltimore, Maryland, 21237

  • Louisiana Hematology Oncology Associates

    Baton Rouge, Louisiana, 70809

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology, PA - Bedford

    Bedford, Texas, 76022

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • Brimingham Hematology and Oncology

    Birmingham, Alabama, 35235

  • Raleigh Hematology Oncology Associates

    Cary, North Carolina, 27511

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • Hematology Oncology Associates of IL

    Chicago, Illinois, 60611

  • Osteopathic Medical Oncology and Hematology

    Clinton Township, Michigan, 48037

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, PA

    Dallas, Texas, 75231

  • The Texas Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • Texas Cancer Center-Denton

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center-Midtown

    Denver, Colorado, 80218

  • North Shore Hematology

    East Setauket, New York, 11733

  • Puget Sound Cancer Center-Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Fort Wayne Medical Oncology Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Texas Oncology, PA

    Fort Worth, Texas, 76104

  • San Antonio Tumor & Blood Clinic

    Fredericksburg, Texas, 78624

  • Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)

    Fresno, California, 93720

  • Texas Oncology, PA

    Garland, Texas, 75042

  • C. Michael Jones, MD

    Germantown, Tennessee, 38138

  • Greeley Medical Clinic Oncology Hematology, PC

    Greeley, Colorado, 80538

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Spalding Oncology Services

    Griffin, Georgia, 30224

  • Northwestern Carolina Ocology Hemato

    Hickory, North Carolina, 28602

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates

    Jacksonville, Florida, 32204

  • Kalamazoo Hematology & Oncology

    Kalamazoo, Michigan, 49048

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Hematology Oncology Associates of Ohio & Michigan

    Lambertville, Michigan, 48144

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Nevada Cancer Centers

    Las Vegas, Nevada, 89109

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Longview Cancer Center

    Longview, Texas, 75601

  • South Texas Cancer Center-McAllen

    McAllen, Texas, 78503

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Monterey Bay Oncology

    Monterey, California, 93940

  • Hematology-Oncology Associates of NNJ, PA

    Morristown, New Jersey, 07960

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10017

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • HOAST - Medical Dr.

    San Antonio, Texas, 78229

  • Puget Sound Cancer Center Seattle

    Seattle, Washington, 98133

  • Northern AZ Hematology & Oncology Assoc

    Sedona, Arizona, 86336

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Hope Center

    Terre Haute, Indiana, 47802

  • Connecticut Oncology & Hematology, LLP

    Torrington, Connecticut, 06790

  • Business Office - ACRC

    Tucson, Arizona, 85715

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Waco Cancer Care and Research Center

    Waco, Texas, 76712

  • Texas Oncology, P.A.

    Webster, Texas, 77598

  • Texas Oncology, PA

    Webster, Texas, 77598

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Yakima Valley mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Randomized PhIII Trial of Cetuximab, Bevacizumab & Biweekly Infusional 5FU/Leucovorin (FOLF-CB) vs. Oxaliplatin, Bevacizumab, & Biweekly Infusional 5FU/Leucovorin (Bev-FOLFOX) in First Line Treatment of Metastatic Colorectal Cancer

The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.

Read the detailed description

This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be randomized on a 1:1 basis to either treatment Arm.

In this trial, we will compare the efficacy, safety, and tolerability of this novel combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB) to the current standard of care, biweekly infusional 5-FU/leucovorin plus oxaliplatin and bevacizumab (Bev-FOLFOX). For practical purposes, this study will be a head to head comparison of oxaliplatin versus cetuximab, since the other components of both regimens will be the same.

Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    5 mg/kg over 30 minutes on Days 1 and 15

  • OxaliplatinDrug

    Also called Eloxatin

    85 mg/m2 on Days 1 and 15

  • LeucovorinDrug

    400 mg/m2 on Days 1 and 15

  • FluorouracilDrug

    Also called 5FU

    400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)

  • CetuximabDrug

    Also called Erbitux

    400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour

Study groups in NCT00252564
Study groupRoleWhat they receive
Bev-FOLFOXExperimental(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle
Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil
FOLF-CBExperimental(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU
Receives: Drug: Bevacizumab; Drug: Leucovorin; Drug: Fluorouracil; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).

    Kaplan-Meier median PFS time and PFS rate (at 12 months)

    Measured: 12 months

  2. Progression-free Survival (PFS) Rate at 1 Year.

    From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).

    Measured: 12 months

Secondary outcomes (2)

  1. Overall Survival (OS)

    From randomization to death (event); or last follow-up date if alive (censoring).

    Kaplan-Meier OS median time.

    Measured: up to 4 years

  2. Objective Response Rate

    Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all "per-protocol population" patients.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionJun 2007
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252564
Sponsor's protocol ID
05-041
Status last verified
Sep 2018
First submitted
9 Nov 2005
Last updated
15 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Oxaliplatin and Leucovorin in people with Metastatic Colorectal Cancer, run by US Oncology Research at 82 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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