Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
ImClone LLC
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00110357
First received: May 6, 2005
Last updated: August 23, 2011
Last verified: August 2011
Results First Received: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Cancer
Refractory Solid Tumor
Interventions: Drug: Cetuximab + Irinotecan
Drug: Cetuximab + Irinotecan

  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
48 subjects were enrolled; 1 additional subject withdrew informed consent before any measurements or treatment. 46 subjects (27 in the 1- to 12-yrs-old group and 19 subjects in the 13- to 18-yrs-old group) were treated; 2 subjects in the 13-18 yrs group were not treated, and are NOT included in Participant Flow or Baseline Characteristics tables.

Reporting Groups
  Description
1- to 12-years-old No text entered.
13- to 18-years-old No text entered.

Participant Flow:   Overall Study
    1- to 12-years-old     13- to 18-years-old  
STARTED     27     19  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     27     19  
Deterioration without progression                 2                 0  
Disease progression/relapse                 20                 15  
Study Closure                 1                 0  
Study Drug Toxicity                 1                 3  
Withdrawal by Subject                 3                 1  
[1] Number Still on Study



  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
1- to 12-years-old No text entered.
13- to 18-years-old No text entered.
Total Total of all reporting groups

Baseline Measures
    1- to 12-years-old     13- to 18-years-old     Total  
Number of Participants  
[units: participants]
  27     19     46  
Age  
[units: years]
Median ( Full Range )
  8.0  
  ( 1.0 to 12.0 )  
  16.0  
  ( 13.0 to 18.0 )  
  10  
  ( 1.0 to 18.0 )  
Gender  
[units: participants]
     
Female     15     9     24  
Male     12     10     22  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     0     2     2  
Black or African American     5     2     7  
White     21     14     35  
Other     1     1     2  
Disease diagnosis  
[units: Participants]
     
CNS Primary Tumor     17     9     26  
Non-CNS Primary Tumor     10     10     20  
Performance Status [1]
[units: Participants]
     
>70-100     19     16     35  
≥50-70     8     3     11  
<50     0     0     0  
[1] For participants ≤10 years of age, Lansky play scale is used; for participants >10 years of age, Karnofsky scale is used. The Lansky scale runs from 100 to 0, where 100 is "fully active/normal" and 0 is "unresponsive." Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan   [ Time Frame: Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1. ]

2.  Secondary:   Number of Participants With a Dose-Limiting Toxicity   [ Time Frame: Prior to each 21-day cycle until dose-limiting toxicities ]

3.  Secondary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

4.  Secondary:   Area Under the Curve, Extrapolated to Infinity (AUC[INF])   [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

5.  Secondary:   Terminal Half-Life (T-Half)   [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

6.  Secondary:   Clearance Corrected for Body Surface Area (CL/BSA)   [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

7.  Secondary:   Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)   [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

8.  Secondary:   Tumor Response   [ Time Frame: Every other 21-day cycle ]

9.  Secondary:   Human Anti-cetuximab Antibody (HACA) Response   [ Time Frame: Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle ]

10.  Secondary:   Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)   [ Time Frame: Weekly throughout the study and every 4 weeks thereafter ]

11.  Secondary:   Grade 3-4 Laboratory Abnormalities - Leukopenia   [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]

12.  Secondary:   Grade 3-4 Laboratory Abnormalities - Neutropenia   [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]

13.  Secondary:   Grade 3-4 Laboratory Abnormalities - Thrombocytopenia   [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]

14.  Secondary:   Grade 3/4 Laboratory Abnormalities - Hypomagnesemia   [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]


  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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00110357     History of Changes
Other Study ID Numbers: CA225-085
Study First Received: May 6, 2005
Results First Received: April 21, 2009
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration