Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

PhII ICb With/Without Erbitux in MBC Pts (CA225200)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00248287
First received: November 2, 2005
Last updated: September 15, 2016
Last verified: September 2016
Results First Received: February 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Irinotecan + Carboplatin
Drug: irinotecan + Carboplatin + erbitux

  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
Irinotecan+Carboplatin Patients treated with Irinotecan + Carboplatin
Irinotecan+Carboplatin+Cetuximab Patients treated with Irinotecan + Carboplatin + Cetuximab

Participant Flow:   Overall Study
    Irinotecan+Carboplatin   Irinotecan+Carboplatin+Cetuximab
STARTED   75   79 
COMPLETED   51   60 
NOT COMPLETED   24   19 
Adverse Event                11                10 
Death                1                0 
Lost to Follow-up                0                1 
Investigator Request                4                3 
Patient Request                5                3 
Other                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.
ITT population

Reporting Groups
  Description
Irinotecan+Carboplatin Patients treated with Irinotecan + Carboplatin
Irinotecan+Carboplatin+Cetuximab Patients treated with Irinotecan + Carboplatin + Cetuximab
Total Total of all reporting groups

Baseline Measures
   Irinotecan+Carboplatin   Irinotecan+Carboplatin+Cetuximab   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   79   154 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.7  (11.4)   54.9  (10.7)   54.3  (11.0) 
Gender 
[Units: Participants]
     
Female   75   79   154 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   59   69   128 
Black   14   8   22 
Hispanic   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   75   79   154 


  Outcome Measures
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1.  Primary:   Objective Response Rates (ORR)   [ Time Frame: 2 years ]

2.  Secondary:   Duration of Response   [ Time Frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months. ]

3.  Secondary:   Median Time of Progression-free Survival (PFS)   [ Time Frame: 2 years ]

4.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 2 years ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Joyce O’Shaughnessy
Organization: Baylor Sammons Cancer Center
phone: (214) 370 -1796
e-mail: Joyce.OShaughnessy@usoncology.com



Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00248287     History of Changes
Other Study ID Numbers: 04070
CA225200 ( Other Identifier: Bristol-Myers-Squibb )
Study First Received: November 2, 2005
Results First Received: February 2, 2016
Last Updated: September 15, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration