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 has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096278
First received: November 9, 2004
Last updated: May 16, 2014
Last verified: July 2013
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Colon
Stage IIA Colon Cancer
Stage IIB Colon Cancer
Stage IIC Colon Cancer
Stage IIIA Colon Cancer
Stage IIIB Colon Cancer
Stage IIIC Colon Cancer
Interventions: Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil
Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Participant Flow:   Overall Study
    Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil     Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab  
STARTED     1356     1354  
COMPLETED     1338     1334  
NOT COMPLETED     18     20  
No follow-up data                 15                 18  
Patient not at risk for primary endpoint                 3                 2  



  Baseline Characteristics


  Outcome Measures

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

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


  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
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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 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: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
phone: 412-330-4600


No publications provided by National Cancer Institute (NCI)

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, U10CA012027
Study First Received: November 9, 2004
Results First Received: October 31, 2012
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration