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Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00098787
First received: December 8, 2004
Last updated: October 6, 2015
Last verified: October 2015
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: bevacizumab
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: Oxaliplatin

  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
This study was activated on July 14, 2005 and terminated on April 20, 2012, with 247 patients from 25 institutions enrolled to the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only 211 patients were registered to the treatment phase of the study, while the other 36 did not proceed because of ineligibility (n=9), patient withdrawal (n=6), unknown thymidylate synthase (TS)/insufficient sample (n=3), disease progression/decline in TS (n=2), Arm C suspended could not enter Step 2 (n =15), and no insurance (n =1).

Reporting Groups
  Description
Arm A (High TS, IROX/Bev) Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Arm B (High TS, FOLFOX/Bev) Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Arm C (Low or Intermediate TS, FOLFOX/Bev) Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.

Participant Flow:   Overall Study
    Arm A (High TS, IROX/Bev)   Arm B (High TS, FOLFOX/Bev)   Arm C (Low or Intermediate TS, FOLFOX/Bev)
STARTED   73   75   63 
Treated   70   73   62 
Eligible and Treated   61   66   59 
COMPLETED   0   0   0 
NOT COMPLETED   73   75   63 
Never started treatment                3                2                1 
Ineligible                9                7                3 
Disease progression                28                17                23 
Adverse Event                8                17                8 
Death                6                1                0 
Withdrawal by Subject                4                12                6 
Alternative therapy                8                13                13 
Other                7                6                9 



  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.
Eligible and treated patients

Reporting Groups
  Description
Arm A (High TS, IROX/Bev) Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Arm B (High TS, FOLFOX/Bev) Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
Arm C (Low or Intermediate TS, FOLFOX/Bev) Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
Total Total of all reporting groups

Baseline Measures
   Arm A (High TS, IROX/Bev)   Arm B (High TS, FOLFOX/Bev)   Arm C (Low or Intermediate TS, FOLFOX/Bev)   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   66   59   186 
Age 
[Units: Years]
Median (Full Range)
 61 
 (37 to 85) 
 60 
 (31 to 79) 
 59 
 (29 to 80) 
 60 
 (29 to 85) 
Gender 
[Units: Participants]
       
Female   21   30   24   75 
Male   40   36   35   111 
Disease status 
[Units: Participants]
       
Initial Diagnosis   50   50   50   150 
Recurrence   11   16   9   36 


  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration. ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration. ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration. ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012



Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00098787     History of Changes
Other Study ID Numbers: CDR0000398096
E4203 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: December 8, 2004
Results First Received: May 27, 2014
Last Updated: October 6, 2015
Health Authority: United States: Federal Government