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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
Not Enrolling
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


- Histologically or cytologically confirmed colorectal cancer with metastatic disease

- Measurable disease

- Previously irradiated lesions will be considered evaluable, if they progressed since

- 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


- 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

- Hypersensitivity to Chinese hamster ovary cell products or other recombinant human

- 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:


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:


Principal Investigator

Allen Cohn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

June 2009

Related Keywords:

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



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