We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00248287
Recruitment Status : Active, not recruiting
First Posted : November 3, 2005
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):
US Oncology Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Irinotecan + Carboplatin
Drug: irinotecan + Carboplatin + erbitux

  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
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

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
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 
[Units: Years]
Mean (Standard Deviation)
 53.7  (11.4)   54.9  (10.7)   54.3  (11.0) 
[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

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

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
No text entered.

  More Information

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 )
First Submitted: November 2, 2005
First Posted: November 3, 2005
Results First Submitted: February 2, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016