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Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096278
First received: November 9, 2004
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: bevacizumab
Drug: 5-fluorouracil
Drug: leucovorin
Drug: oxaliplatin

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Total Total of all reporting groups

Baseline Measures
    Oxaliplatin + Leucovorin + 5-Fluorouracil     Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab     Total  
Number of Participants  
[units: participants]
 		  1356     1354     2710  
Age  
[units: years]
Mean ± Standard Deviation 		  57  ± 11.6     56  ± 11.3     57  ± 11.4  
Gender  
[units: participants]
 		     
Female     680     678     1358  
Male     676     676     1352  



  Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: 3 years ]
  Show Outcome Measure 1

2.  Secondary:   Survival as Assessed by Death From Any Cause   [ Time Frame: Every 6 months for 4 years and then every 12 months until death from any cause ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Proteinuria After Completion of Bevacizumab   [ Time Frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Proteinuria With Clinical Sequelae   [ Time Frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   The Risk Factors for Development of Proteinuria   [ Time Frame: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   As Measured by Blood Pressure and Antihypertensive Medication Hypertension   [ Time Frame: Group 2, every 3 months for one year post treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab   [ Time Frame: Events measured regularly during chemotherapy and bevacizumab therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test   [ Time Frame: Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab   [ Time Frame: Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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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 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 less than or equal to 60 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.


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.  


Results Point of Contact:  
Name/Title: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
phone: 412-330-4600


Publications of Results:
Allegra CJ, Yothers G, O'Connell MJ, et al.: Initial safety report of NSABP C-08, a randomized phase III study of modified 5-fluorouracil (5-FU)/leucovorin (LCV) and oxaliplatin (OX) (mFOLFOX6) with or without bevacizumab (bev) in the adjuvant treatment of patients with stage II/III colon cancer. [Abstract] J Clin Oncol 26 (Suppl 15): A-4006, 2008.

Publications automatically indexed to this study:


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096278     History of Changes
Other Study ID Numbers: NCI-2012-03017, NSABP C-08
Study First Received: November 9, 2004
Results First Received: October 31, 2012
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration