Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer Metastatic

Thank you

Trial Information

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


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.

Inclusion Criteria


INCLUSION CRITERIA:

- 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

- 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

EXCLUSION CRITERIA:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

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)

Outcome Time Frame:

(no pre-determined maximum time)

Safety Issue:

No

Principal Investigator

Allen Cohn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Institutional Review Board

Study ID:

05-041

NCT ID:

NCT00252564

Start Date:

September 2005

Completion Date:

June 2009

Related Keywords:

  • Colorectal Cancer Metastatic
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Tyler Cancer CenterTyler, Texas  75702
Hope CenterTerre Haute, Indiana  47809
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
Monterey Bay OncologyMonterey, California  93940
Cancer Centers of Florida, P.A.Orlando, Florida  
Rocky Mountain Cancer Center-MidtownDenver, Colorado  80218
Texas Oncology, PADallas, Texas  75246-2006
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Medical Oncology AssociatesKingston, Pennsylvania  18704
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
West Texas Cancer CenterOdessa, Texas  79761
Center for Cancer & Blood DisordersBethesda, Maryland  20817
Hematology Oncology AssociatesPhoenix, Arizona  85012
Greater Dayton Cancer CenterKettering, Ohio  45409
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
The Texas Cancer CenterDallas, Texas  75237
San Antonio Tumor & Blood ClinicFredericksburg, Texas  78624
Lake Vista Cancer CenterLewisville, Texas  75067
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Nevada Cancer CentersLas Vegas, Nevada  89109
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Spalding Oncology ServicesGriffin, Georgia  30224
Cancer Center of KansasWichita, Kansas  67214
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
New York Oncology Hematology, PCAlbany, New York  12208
Kalamazoo Hematology & OncologyKalamazoo, Michigan  49048
Maryland Oncology Hematology, P.A.Columbia, Maryland  21044
Paris Regional Cancer CenterParis, Texas  75460
Waco Cancer Care and Research CenterWaco, Texas  76712
Hematology Oncology Associates of Ohio & MichiganLambertville, Michigan  48144
Hematology Oncology Associates of ILChicago, Illinois  60611
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Northern AZ Hematology & Oncology AssocSedona, Arizona  86336
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
El Paso Cancer Treatment CtrEl Paso, Texas  79915
South Texas Cancer Center-McAllenMcAllen, Texas  78503
Texas Cancer Center-ShermanSherman, Texas  75090
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Cancer Care Northwest-SouthSpokane, Washington  99202
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Puget Sound Cancer Center-EdmondsEdmonds, Washington  98026
Brimingham Hematology and OncologyBirmingham, Alabama  35235
Business Office - ACRCTucson, Arizona  85715
Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)Fresno, California  93720
Greeley Medical Clinic Oncology Hematology, PCGreeley, Colorado  80538
Connecticut Oncology & Hematology, LLPTorrington, Connecticut  06790
Integrated Community Oncology Network (ICON) / fka:Florida Oncology AssociatesJacksonville, Florida  32204
Medical Oncology Associates of Augusta PCAugusta, Georgia  30901
Fort Wayne Medical Oncology Hematology, IncFort Wayne, Indiana  46815
Kansas City Cancer Centers-SouthwestOverland Park, Kansas  66210
Louisiana Hematology Oncology AssociatesBaton Rouge, Louisiana  70809
Auerbach Hematology Oncology AssociatedBaltimore, Maryland  21237
Osteopathic Medical Oncology and HematologyClinton Township, Michigan  48037
Hematology-Oncology Associates of NNJ, PAMorristown, New Jersey  07960
North Shore HematologyEast Setauket, New York  11733
Northwestern Carolina Ocology HematoHickory, North Carolina  28602
Cancer Center Associates of Carolina, PA / fka Carolina Cancer CenterAiken, South Carolina  29801
C. Michael Jones, MDGermantown, Tennessee  38138
Texas Cancer Center-Abilene (Shouth)Abilene, Texas  79606
Texas Oncology, PA - BedfordBedford, Texas  76022
Texas Cancer Center-DentonDenton, Texas  76210
HOAST - Medical Dr.San Antonio, Texas  78229
Puget Sound Cancer Center SeattleSeattle, Washington  98133