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Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00193219
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 7, 2013
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE December 7, 2012
Results First Posted Date  ICMJE March 7, 2013
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE July 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Overall response rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
  • Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]
    Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
  • Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 36 months ]
    Measured from the date of first treatment until the date of death from any cause
  • Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Progression free survival
  • Overall survival
  • Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer
Brief Summary This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.
Detailed Description All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously (IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85 mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified FOLFOX6). Cycles were 14 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Drug: Bevacizumab
    5 mg/kg IV
    Other Name: Avastin
  • Drug: Cetuximab
    400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8
    Other Name: Erbitux
  • Drug: 5-fluorouracil
    400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)
    Other Names:
    • 5-FU
    • Adrucil
  • Drug: Leucovorin
    350 mg IV
    Other Name: Folinic Acid
  • Drug: Oxaliplatin
    85 mg/m2 IV
    Other Name: Eloxatin
Study Arms  ICMJE Experimental: Intervention

Bevacizumab 5 mg/kg IV

Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8

5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient)

Leucovorin 350 mg IV

Oxaliplatin 85 mg/m2 IV

Interventions:
  • Drug: Bevacizumab
  • Drug: Cetuximab
  • Drug: 5-fluorouracil
  • Drug: Leucovorin
  • Drug: Oxaliplatin
Publications * Spigel DR, Greco FA, Waterhouse D, Shipley D, Lane CM, Vazquez ER, Clark BL, Infante JR, Bendell JC, Burris HA 3rd, Hainsworth JD. Phase II trial of FOLFOX6, bevacizumab, and cetuximab in the first-line treatment of metastatic colorectal cancer. Clin Adv Hematol Oncol. 2010 Jul;8(7):480-5, 498.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2013)
36
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
70
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

  • Metastatic colorectal cancer confirmed by a biopsy sample
  • 18 years of age or older
  • Evidence of disease progression at time of study entry
  • At least one prior adjuvant chemotherapy regimen
  • No prior therapy for metastatic disease
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • Adequate bone marrow, kidney, and liver function
  • Tumor tissue available for assessment of EGFR
  • Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

  • Treatment with a previous regimen for metastatic disease
  • Prior treatment with any EGFR inhibitor or anti-angiogenic agents
  • Brain or nervous system metastases
  • History of severe thromboembolic event
  • Clinical evidence or history of bleeding or coagulopathy
  • History of stroke or heart attack within six months
  • Poorly controlled hypertension
  • Non-healing wound, ulcer, or bone fracture
  • History of abdominal fistula, perforation, or abscess within six months
  • Other uncontrolled or significant disease or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00193219
Other Study ID Numbers  ICMJE SCRI GI 64
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SCRI Development Innovations, LLC
Study Sponsor  ICMJE SCRI Development Innovations, LLC
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
PRS Account SCRI Development Innovations, LLC
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP