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

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ClinicalTrials.gov Identifier: NCT00408499
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: cetuximab
Drug: erlotinib
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Phase II- Dose Expansion
Hide Arm/Group Description 100 mg Erlotinib, 150 mg/m2 Cetuximab 100 mg Erlotinib, 200 mg/m2 Cetuximab 100 mg Erlotinib, 250 mg/m2 Cetuximab 150 mg Erlotinib, 250 mg/m2 Cetuximab Phase II dose expansion at determined MTD
Period Title: Phase 1: Dose Levels 1-4
Started 4 7 3 6 0
Completed 2 5 2 6 0
Not Completed 2 2 1 0 0
Reason Not Completed
Adverse Event             0             0             1             0             0
Withdrawal by Subject             1             1             0             0             0
Physician Decision             1             1             0             0             0
Period Title: Phase II- MTD Expansion
Started 0 0 0 0 44
Completed 0 0 0 0 24
Not Completed 0 0 0 0 20
Reason Not Completed
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
Arm/Group Title Erlotinib + Cetuximab
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  50.0%
>=65 years
32
  50.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants
62.91
(38 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
30
  46.9%
Male
34
  53.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Hispanic or Latino
2
   3.1%
Not Hispanic or Latino
61
  95.3%
Unknown or Not Reported
1
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 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%
1.Primary Outcome
Title Number of Patients Experiencing a DLT
Hide Description Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity
Time Frame baseline through cycle 1 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Hide Arm/Group Description:
100 mg Erlotinib, 150 mg/m2 Cetuximab
100 mg Erlotinib, 200 mg/m2 Cetuximab
100 mg Erlotinib, 250 mg/m2 Cetuximab
150 mg Erlotinib, 250 mg/m2 Cetuximab
Overall Number of Participants Analyzed 4 7 3 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4
Comments [Not Specified]
Type of Statistical Test Other
Comments Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.
Method of Estimation Estimation Parameter Maximum tolerated dose
Estimated Value 4
Estimation Comments Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab
2.Primary Outcome
Title Number of Patients Correlated With Best Overall Response.
Hide Description To determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.
Time Frame Every two cycles from first dose to last dose of study drugs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib + Cetuximab
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 64
Measure Type: Count of Participants
Unit of Measure: Participants
Complete/Partial response
2
   3.1%
Stable Disease
19
  29.7%
Progressive disease
22
  34.4%
Not evaluable
21
  32.8%
3.Secondary Outcome
Title Patient Outcome
Hide Description In the Phase II portion of the study, patients will be followed for both disease free progression by capturing disease progression date and for over all survival by capturing death date.
Time Frame Patients will be followed until death
Hide Outcome Measure Data
Hide Analysis Population Description
44 patients were enrolled into the Phase II portion of the study
Arm/Group Title Phase II Expansion
Hide Arm/Group Description:
44 Patients at dose level 4 phase II expansion: 150 mg Erlotinib, 250 mg/m2 Cetuximab
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
Deceased
29
  65.9%
Not followed
9
  20.5%
Withdrew consent
4
   9.1%
Alive when study terminated
2
   4.5%
Time Frame Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib + Cetuximab
Hide Arm/Group Description

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.

All-Cause Mortality
Erlotinib + Cetuximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib + Cetuximab
Affected / at Risk (%)
Total   4/64 (6.25%) 
Cardiac disorders   
Thrombosis/thrombus/embolism  1  1/64 (1.56%) 
Gastrointestinal disorders   
Vomiting  1  1/64 (1.56%) 
Nausea  1  1/64 (1.56%) 
Bronchospasm  1  1/64 (1.56%) 
Nervous system disorders   
Dizziness  1  1/64 (1.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib + Cetuximab
Affected / at Risk (%)
Total   64/64 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  13/64 (20.31%) 
Leukopenia  1  8/64 (12.50%) 
Lymphopenia  1  21/64 (32.81%) 
Gastrointestinal disorders   
Anorexia  1  7/64 (10.94%) 
Constipation  1  5/64 (7.81%) 
Diarrhea  1  25/64 (39.06%) 
Heartburn  1  3/64 (4.69%) 
Mucositis  1  12/64 (18.75%) 
Nausea  1  18/64 (28.13%) 
Vomiting  1  11/64 (17.19%) 
General disorders   
Edema limbs  1  4/64 (6.25%) 
Fatigue  1  31/64 (48.44%) 
Fever  1  4/64 (6.25%) 
Investigations   
Alanine aminotransferase increased  1  7/64 (10.94%) 
Aspartate aminotransferase Increased  1  18/64 (28.13%) 
Bilirubin increased  1  13/64 (20.31%) 
Creatinine Increased  1  5/64 (7.81%) 
Alkaline phosphatase increased  1  9/64 (14.06%) 
Metabolism and nutrition disorders   
Dehydration  1  3/64 (4.69%) 
Hyperglycemia  1  3/64 (4.69%) 
Hypoalbuminemia  1  12/64 (18.75%) 
Hypocalcemia  1  8/64 (12.50%) 
Hypokalemia  1  11/64 (17.19%) 
Hypomagnesemia  1  27/64 (42.19%) 
Hyponatremia  1  11/64 (17.19%) 
Hypophosphatemia  1  5/64 (7.81%) 
Nervous system disorders   
Dizziness  1  5/64 (7.81%) 
Headache  1  6/64 (9.38%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/64 (4.69%) 
Skin and subcutaneous tissue disorders   
Acneiform rash  1  43/64 (67.19%) 
Dry Skin  1  21/64 (32.81%) 
Nail Changes  1  4/64 (6.25%) 
Pruritus  1  8/64 (12.50%) 
Rash NOS  1  19/64 (29.69%) 
Rash desquamtion  1  10/64 (15.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Data Manager
Organization: University of California, Davis
Phone: 916-734-8381
EMail: nmahaffey@ucdavis.edu
Layout table for additonal information
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 )
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: January 19, 2017
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017