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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 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
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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.
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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 ]

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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description Participants at Risk includes any patient who submitted an Adverse Event (AE) form.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Other Adverse Events
    Oxaliplatin + Leucovorin + 5-Fluorouracil     Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab  
Total, other (not including serious) adverse events      
# participants affected / at risk     954/1326     1043/1334  
Gastrointestinal disorders      
Diarrhea † 1    
# participants affected / at risk     128/1326 (9.65%)     153/1334 (11.47%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     98/1326 (7.39%)     122/1334 (9.15%)  
Investigations      
Neutrophil count decreased † 1    
# participants affected / at risk     433/1326 (32.65%)     400/1334 (29.99%)  
White blood cell decreased † 1    
# participants affected / at risk     73/1326 (5.51%)     58/1334 (4.35%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     53/1326 (4.00%)     67/1334 (5.02%)  
Nervous system disorders      
Peripheral sensory neuropathy † 1    
# participants affected / at risk     586/1326 (44.19%)     660/1334 (49.48%)  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     53/1326 (4.00%)     70/1334 (5.25%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     24/1326 (1.81%)     172/1334 (12.89%)  
Thromboembolic event † 1    
# participants affected / at risk     64/1326 (4.83%)     85/1334 (6.37%)  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE v4.0



  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