Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

This study has been terminated.
(Due to inadequate accrual, study was terminated and limited outcome data was reported.)
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00499369
First received: July 10, 2007
Last updated: July 25, 2014
Last verified: March 2014
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions: Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Biological: bevacizumab

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Cohort I: Chemotherapy + Cetuximab Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)

Participant Flow:   Overall Study
    Cohort I: Chemotherapy + Cetuximab     Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab     Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab     Cohort II: Chemotherapy + Cetuximab     Cohort II: Chemotherapy + Bevacizumab  
STARTED     16     18     17     9     12  
Eligible     14     16     16     8     12  
COMPLETED     0     0     0     0     0  
NOT COMPLETED     16     18     17     9     12  
Adverse Event                 2                 2                 3                 1                 2  
Withdrawal by Subject                 0                 1                 1                 0                 0  
Progression                 10                 12                 9                 6                 10  
Death                 0                 1                 0                 0                 0  
Not protocol specified                 2                 0                 3                 1                 0  
Ineligible                 2                 2                 1                 1                 0  



  Baseline Characteristics
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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.
All eligible patients are included in this analysis.

Reporting Groups
  Description
Cohort I: Chemotherapy + Cetuximab Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Cetuximab Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Cohort II: Chemotherapy + Bevacizumab Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Total Total of all reporting groups

Baseline Measures
    Cohort I: Chemotherapy + Cetuximab     Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab     Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab     Cohort II: Chemotherapy + Cetuximab     Cohort II: Chemotherapy + Bevacizumab     Total  
Number of Participants  
[units: participants]
  14     16     16     8     12     66  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 44 to 76 )  
  63  
  ( 37 to 77 )  
  58  
  ( 46 to 75 )  
  65  
  ( 47 to 73 )  
  59  
  ( 38 to 70 )  
  60  
  ( 37 to 77 )  
Gender  
[units: participants]
           
Female     6     8     5     2     7     28  
Male     8     8     11     6     5     38  
Ethnicity (NIH/OMB)  
[units: participants]
           
Hispanic or Latino     2     3     2     2     2     11  
Not Hispanic or Latino     12     13     12     6     9     52  
Unknown or Not Reported     0     0     2     0     1     3  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native     0     0     1     0     0     1  
Asian     0     0     1     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0  
Black or African American     1     2     0     0     0     3  
White     11     12     12     7     11     53  
More than one race     0     0     0     0     0     0  
Unknown or Not Reported     2     2     2     1     1     8  
Performance Status [1]
[units: participants]
           
0     9     8     8     1     4     30  
>= 1     5     8     8     7     8     36  
Discontinuation of oxaliplatin while on first-line treatment  
[units: participants]
           
Discontinued     5     9     8     4     9     35  
Did not discontinue     9     7     8     4     3     31  
Planned concurrent chemotherapy  
[units: participants]
           
FOLFIRI     10     11     12     5     8     46  
Single-agent irinotecan     4     5     4     3     4     20  
Time from last dose of bevacizumab  
[units: participants]
           
14-42 days     12     13     13     6     8     52  
43 days or higher     2     3     3     2     4     14  
[1] Patients graded according to the Zubrod Performance Status Scale: 0 is fully active, able to carry on all pre-disease performance without restriction; 1 is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 is ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours; 3 is capable of limited self-care, confined to bed or chair more than 50% of waking hours; and 4 is completely disabled, cannot carry on any self-care, totally confined to bed or chair.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   Objective Tumor Response   [ Time Frame: Up to 5 years ]

4.  Secondary:   Toxicity   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Due to inadequate accrual, study was terminated and limited outcome data was reported.


  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: Study Statistician
Organization: SWOG
phone: 206-667-4623


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499369     History of Changes
Other Study ID Numbers: NCI-2009-00784, NCI-2009-00784, CALGB-SWOG-S0600, SWOG-S0600, CDR0000551934, ECOG-SWOG-S0600, CAN-NCIC-SWOG-S0600, NCCTG-SWOG-S0600, S0600, S0600, U10CA032102
Study First Received: July 10, 2007
Results First Received: October 22, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration