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Trial record 22 of 327 for:    "Adenocarcinoma of lung"

Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

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ClinicalTrials.gov Identifier: NCT00716456
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Adenocarcinoma
Intervention: Drug: erlotinib with cetuximab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Protocol Open to Accrual: 7/15/2008

Protocol Closed to Accrual: 5/25/2010

Primary Completion Date: 5/24/2011

Recruitment Location is the Medical Clinic


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
Cetuximab 250 mg/m2 Cetuximab 250 mg/m2 IV every two weeks
Cetuximab 375 mg/m2 Cetuximab 375 mg/m2 IV every two weeks
Cetuximab 500 mg/m2 Cetuximab 500 mg/m2 IV every two weeks

Participant Flow:   Overall Study
    Cetuximab 250 mg/m2   Cetuximab 375 mg/m2   Cetuximab 500 mg/m2
STARTED   3   5   13 
COMPLETED   3   3   13 
NOT COMPLETED   0   2   0 
Adverse Event                0                2                0 



  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.
No text entered.

Reporting Groups
  Description
Cetuximab 250 mg/m2 Cetuximab 250 mg/m2 IV every two weeks
Cetuximab 375 mg/m2 Cetuximab 375 mg/m2 IV every two weeks
Cetuximab 500 mg/m2 Cetuximab 500 mg/m2 IV every two weeks
Total Total of all reporting groups

Baseline Measures
   Cetuximab 250 mg/m2   Cetuximab 375 mg/m2   Cetuximab 500 mg/m2   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   5   13   21 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   1   2   9   12 
>=65 years   2   3   4   9 
Gender 
[Units: Participants]
       
Female   1   4   9   14 
Male   2   1   4   7 
Region of Enrollment 
[Units: Participants]
       
United States   3   5   13   21 


  Outcome Measures

1.  Primary:   The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks   [ Time Frame: At conclusion of study, up to 24 weeks ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Gregory J. Riely
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4199
e-mail: rielyg@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00716456     History of Changes
Other Study ID Numbers: 08-055
First Submitted: July 15, 2008
First Posted: July 16, 2008
Results First Submitted: March 31, 2015
Results First Posted: April 30, 2015
Last Update Posted: April 30, 2015