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A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00069121
First received: September 15, 2003
Last updated: August 13, 2013
Last verified: August 2013
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: capecitabine [Xeloda]
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5 FU

  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
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
5-FU/LV

Given by one of two regimens.

  • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
  • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
XELOX Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)

Participant Flow:   Overall Study
    5-FU/LV     XELOX  
STARTED     942     944  
Received Treatment     926 [1]   938 [1]
COMPLETED     640 [2]   668 [2]
NOT COMPLETED     302     276  
Death                 225                 197  
Withdrawal by Subject                 20                 22  
Lost to Follow-up                 57                 57  
[1] Safety Population
[2] total includes Completed and Alive in follow-up



  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.
No text entered.

Reporting Groups
  Description
5-FU/LV

Given by one of two regimens.

  • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or
  • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
XELOX Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Total Total of all reporting groups

Baseline Measures
    5-FU/LV     XELOX     Total  
Number of Participants  
[units: participants]
  942     944     1886  
Age  
[units: years]
Mean ± Standard Deviation
  60.5  ± 10.76     59.8  ± 10.95     60.2  ± 10.86  
Gender  
[units: participants]
     
Female     442     431     873  
Male     500     513     1013  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease-free Survival (DFS) [Number of Events]   [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ]

2.  Primary:   Disease-free Survival [Time to Event]   [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ]

3.  Secondary:   Relapse-free Survival (RFS) [Number of Events]   [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ]

4.  Secondary:   Relapse-free Survival (RFS) [Time to Event]   [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ]

5.  Secondary:   Overall Survival [Number of Events]   [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ]

6.  Secondary:   Overall Survival [Time to Event]   [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ]

7.  Secondary:   Number of Participants Assesed for Adverse Events   [ Time Frame: followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake ]


  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 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 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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069121     History of Changes
Obsolete Identifiers: NCT00080691
Other Study ID Numbers: NO16968
Study First Received: September 15, 2003
Results First Received: March 31, 2011
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration