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Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Bristol-Myers Squibb
Aptuit Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00265850
First received: December 14, 2005
Last updated: March 13, 2017
Last verified: March 2017
Results First Received: March 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: bevacizumab
Biological: cetuximab
Drug: FOLFOX or
Drug: FOLFIRI

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
From 5/2005 to 9/2009, patients were randomized 1:1:1 to Arms A, B and C. Study was amended in 2009 to include only KRAS wild type patients; then Arm C was closed based on data showing no benefit from chemo with the combination of Bevacizumab and an EGFR antibody. Thereafter, only KRAS wild type patients were randomized 1:1 to Arm A and B.

Reporting Groups
  Description
Arm A: FOLFOX or FOLFIRI + Bevacizumab

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Arm B: FOLFOX or FOLFIRI + Cetuximab

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.


Participant Flow:   Overall Study
    Arm A: FOLFOX or FOLFIRI + Bevacizumab   Arm B: FOLFOX or FOLFIRI + Cetuximab   Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
STARTED   899   902   533 
COMPLETED   899   902   533 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
During the trial, it was learned that KRAS mutation predicted for lack of efficacy of EGFR antibodies; also studies showed no benefit from chemo combined with both Bevacizumab and an EGFR antibody. The trial was amended to 2 arms limited to KRAS wild type patients. Only confirmed and consented KRAS wild type patients were analyzed.

Reporting Groups
  Description
Arm A: FOLFOX or FOLFIRI + Bevacizumab

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Arm B: FOLFOX or FOLFIRI + Cetuximab

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Total Total of all reporting groups

Baseline Measures
   Arm A: FOLFOX or FOLFIRI + Bevacizumab   Arm B: FOLFOX or FOLFIRI + Cetuximab   Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 559   578   0   1137 
Age 
[Units: Years]
Median (Full Range)
 59 
 (21.8 to 85) 
 59.2 
 (20.8 to 89.5) 
    59.1 
 (20.8 to 89.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      211  37.7%      229  39.6%         440  38.7% 
Male      348  62.3%      349  60.4%         697  61.3% 
Region of Enrollment 
[Units: Participants]
       
Canada   32   32      64 
United States   527   546      1073 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Up to 5 years post-treatment ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 5 years post-treatment ]

3.  Secondary:   Time to Treatment Failure   [ Time Frame: Up to 5 years post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Duration of Tumor Response   [ Time Frame: Up to 5 years post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alan Venook, M.D.
Organization: Alliance for Clinical Trials in Oncology
e-mail: Venook@cc.ucsf.edu


Publications of Results:
Other Publications:
Schrag D, Naughton M, Kesselheim A, et al.: Clinical trial participants' strategies for coping with prescription drug costs: A companion study to CALGB 80405. [Abstract] J Clin Oncol 27 (Suppl 15): A-9503, 2009.


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00265850     History of Changes
Other Study ID Numbers: CALGB 80405
U10CA037447 ( US NIH Grant/Contract Award Number )
CDR0000455161 ( Other Identifier: Physician Data Query )
NCI-2009-00434 ( Registry Identifier: NCI Clinical Trial Reporting Program Office )
Study First Received: December 14, 2005
Results First Received: March 13, 2017
Last Updated: March 13, 2017