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

Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00103207
First received: February 7, 2005
Last updated: December 3, 2012
Last verified: December 2012
Results First Received: December 3, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Biological: cetuximab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to accrual on August 10, 2005 and closed to accrual on December 12, 2008 with final accrual of 72 patients.

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

Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.

Only eligible patients with confirmed diagnosis are included in the main analysis.


Participant Flow:   Overall Study
    Cetuximab
STARTED   72 
Eligible Patients w/ Confirmed Diagnosis   41 
Eligible Patients w/ Smoking Status Data   37 
COMPLETED   34 
NOT COMPLETED   38 
Adverse Event                3 
Death                1 
Withdrawal by Subject                2 
Other complicating disease                1 
Ineligible                4 
Diagnosis of BAC not confirmed                27 



  Baseline Characteristics
  Hide 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

Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.

Only eligible patients with confirmed diagnosis are included in the main analysis.


Baseline Measures
   Cetuximab 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age 
[Units: Years]
Median (Full Range)
 70 
 (26 to 90) 
Gender 
[Units: Participants]
 
Female   21 
Male   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (Proportion of Patients With Objective Response)   [ Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ]

3.  Secondary:   Time to Progression   [ Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years ]

4.  Secondary:   Overall Survival by Smoking Status   [ Time Frame: Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ]

5.  Secondary:   Time to Progression by Smoking Status   [ Time Frame: Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications of Results:

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00103207     History of Changes
Other Study ID Numbers: CDR0000409755
U10CA021115 ( US NIH Grant/Contract Award Number )
E1504 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
Study First Received: February 7, 2005
Results First Received: December 3, 2012
Last Updated: December 3, 2012
Health Authority: United States: Federal Government