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Trial record 22 of 331 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
Enrollment 21
Recruitment Details

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  
Arm/Group Title Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2
Hide Arm/Group Description Cetuximab 250 mg/m2 IV every two weeks Cetuximab 375 mg/m2 IV every two weeks Cetuximab 500 mg/m2 IV every two weeks
Period Title: Overall Study
Started 3 5 13
Completed 3 3 13
Not Completed 0 2 0
Reason Not Completed
Adverse Event             0             2             0
Arm/Group Title Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2 Total
Hide Arm/Group Description Cetuximab 250 mg/m2 IV every two weeks Cetuximab 375 mg/m2 IV every two weeks Cetuximab 500 mg/m2 IV every two weeks Total of all reporting groups
Overall Number of Baseline Participants 3 5 13 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 13 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  33.3%
2
  40.0%
9
  69.2%
12
  57.1%
>=65 years
2
  66.7%
3
  60.0%
4
  30.8%
9
  42.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 13 participants 21 participants
Female
1
  33.3%
4
  80.0%
9
  69.2%
14
  66.7%
Male
2
  66.7%
1
  20.0%
4
  30.8%
7
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 5 participants 13 participants 21 participants
3 5 13 21
1.Primary Outcome
Title The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks
Hide Description To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)
Time Frame At conclusion of study, up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2
Hide Arm/Group Description:
Cetuximab 250 mg/m2 IV every two weeks
Cetuximab 375 mg/m2 IV every two weeks
Cetuximab 500 mg/m2 IV every two weeks
Overall Number of Participants Analyzed 3 5 13
Measure Type: Number
Unit of Measure: mg/m2 of CETUXIMAB
500 500 500
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2
Hide Arm/Group Description Cetuximab 250 mg/m2 IV every two weeks Cetuximab 375 mg/m2 IV every two weeks Cetuximab 500 mg/m2 IV every two weeks
All-Cause Mortality
Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      2/5 (40.00%)      5/13 (38.46%)    
Gastrointestinal disorders       
Abdominal pain  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  2
General disorders       
Fatigue  2  0/3 (0.00%)  0 1/5 (20.00%)  1 0/13 (0.00%)  0
Gait disturbance  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Pain  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Immune system disorders       
Allergic reaction/Hypersensitivity  2  0/3 (0.00%)  0 1/5 (20.00%)  1 0/13 (0.00%)  0
Investigations       
Alanine aminotransferase increased  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Aspartate aminotransferase  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Metabolism and nutrition disorders       
Hyperkalemia  2  0/3 (0.00%)  0 1/5 (20.00%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain  2  1/3 (33.33%)  1 0/5 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders       
Ataxia  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Hydrocephalus  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders       
Renal Failure  3  0/3 (0.00%)  0 1/5 (20.00%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  1/3 (33.33%)  1 0/5 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash acneiform  2  1/3 (33.33%)  1 0/5 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders       
Hypotension  2  0/3 (0.00%)  0 0/5 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v 3.0
2
Term from vocabulary, CTCAE (3.0)
3
Term from vocabulary, CTC (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab 250 mg/m2 Cetuximab 375 mg/m2 Cetuximab 500 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/5 (60.00%)      12/13 (92.31%)    
Gastrointestinal disorders       
Diarrhea  1  1/3 (33.33%)  1 1/5 (20.00%)  2 7/13 (53.85%)  15
Mucositis-Oral  1  1/3 (33.33%)  1 2/5 (40.00%)  2 4/13 (30.77%)  8
Nausea  1  1/3 (33.33%)  2 0/5 (0.00%)  0 7/13 (53.85%)  10
Vomiting  1  0/3 (0.00%)  0 0/5 (0.00%)  0 4/13 (30.77%)  4
General disorders       
Fatigue  1  2/3 (66.67%)  8 3/5 (60.00%)  3 5/13 (38.46%)  9
Fever  1  1/3 (33.33%)  1 1/5 (20.00%)  2 3/13 (23.08%)  3
Infections and infestations       
Inf unknown ANC-Ungual (Nails)  1  0/3 (0.00%)  0 2/5 (40.00%)  4 0/13 (0.00%)  0
Metabolism and nutrition disorders       
Hypomagnesemia  1  0/3 (0.00%)  0 2/5 (40.00%)  6 4/13 (30.77%)  27
Hyperkalemia  1  0/3 (0.00%)  0 0/5 (0.00%)  0 2/13 (15.38%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/3 (0.00%)  0 0/5 (0.00%)  0 2/13 (15.38%)  2
Hemorrhage, Nose  1  0/3 (0.00%)  0 1/5 (20.00%)  1 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders       
Dry Skin  1  0/3 (0.00%)  0 1/5 (20.00%)  2 1/13 (7.69%)  1
Pruritus  1  0/3 (0.00%)  0 1/5 (20.00%)  5 2/13 (15.38%)  2
Rash/desquamation  1  0/3 (0.00%)  0 3/5 (60.00%)  15 11/13 (84.62%)  17
Rash acne/acneiform  1  3/3 (100.00%)  3 1/5 (20.00%)  3 0/13 (0.00%)  0
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
Name/Title: Dr. Gregory J. Riely
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4199
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