Text Size

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
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

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
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Show More Information