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Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00408499
First received: December 6, 2006
Last updated: March 27, 2017
Last verified: January 2017
Results First Received: January 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: cetuximab
Drug: erlotinib

  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
No text entered.

Reporting Groups
  Description
Dose Level 1 100 mg Erlotinib, 150 mg/m2 Cetuximab
Dose Level 2 100 mg Erlotinib, 200 mg/m2 Cetuximab
Dose Level 3 100 mg Erlotinib, 250 mg/m2 Cetuximab
Dose Level 4 150 mg Erlotinib, 250 mg/m2 Cetuximab
Phase II- Dose Expansion Phase II dose expansion at determined MTD

Participant Flow for 2 periods

Period 1:   Phase 1: Dose Levels 1-4
    Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4   Phase II- Dose Expansion
STARTED   4   7   3   6   0 
COMPLETED   2   5   2   6   0 
NOT COMPLETED   2   2   1   0   0 
Adverse Event                0                0                1                0                0 
Withdrawal by Subject                1                1                0                0                0 
Physician Decision                1                1                0                0                0 

Period 2:   Phase II- MTD Expansion
    Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4   Phase II- Dose Expansion
STARTED   0   0   0   0   44 
COMPLETED   0   0   0   0   24 
NOT COMPLETED   0   0   0   0   20 
Adverse Event                0                0                0                0                9 
Death                0                0                0                0                2 
Physician Decision                0                0                0                0                1 
Withdrawal by Subject                0                0                0                0                5 
treatment delay                0                0                0                0                3 



  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
Erlotinib + Cetuximab

cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.

erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.


Baseline Measures
   Erlotinib + Cetuximab 
Overall Participants Analyzed 
[Units: Participants]
 64 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      32  50.0% 
>=65 years      32  50.0% 
Age 
[Units: Years]
Mean (Full Range)
 62.91 
 (38 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      30  46.9% 
Male      34  53.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   3.1% 
Not Hispanic or Latino      61  95.3% 
Unknown or Not Reported      1   1.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      5   7.8% 
Native Hawaiian or Other Pacific Islander      1   1.6% 
Black or African American      3   4.7% 
White      54  84.4% 
More than one race      0   0.0% 
Unknown or Not Reported      1   1.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Experiencing a DLT   [ Time Frame: baseline through cycle 1 of treatment ]

2.  Primary:   Number of Patients Correlated With Best Overall Response.   [ Time Frame: Every two cycles from first dose to last dose of study drugs ]

3.  Secondary:   Patient Outcome   [ Time Frame: Patients will be followed until death ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Data Manager
Organization: University of California, Davis
phone: 916-734-8381
e-mail: nmahaffey@ucdavis.edu



Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00408499     History of Changes
Other Study ID Numbers: CDR0000517090
P30CA093373 ( U.S. NIH Grant/Contract )
UCDCC-177 ( Other Identifier: University of California Davis )
BMS-4608 ( Other Identifier: Bristol Myers Squibb )
BMS-CA225-261 ( Other Identifier: Bristol Myers Squibb )
Study First Received: December 6, 2006
Results First Received: January 19, 2017
Last Updated: March 27, 2017