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Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
ImClone LLC
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00112294
First received: June 1, 2005
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
Results First Received: June 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small-Cell Lung Carcinoma
Interventions: Drug: Paclitaxel (Taxane)
Drug: Docetaxel (Taxane)
Drug: Carboplatin
Drug: Cetuximab

  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
755 participants were enrolled and 676 were randomized into the study. 79 participants were not randomized (6 deaths; 1 lost to follow up; 1 poor/non-compliance; 49 no longer met study criteria; 17 participant request; 2 required concurrent radiation; 1 insurance issue; 1 doctor discretion; 1 unknown).

Reporting Groups
  Description
Cetuximab+Taxane+Carboplatin (C/T/C) Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
Taxane+Carboplatin (T/C) A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Participant Flow:   Overall Study
    Cetuximab+Taxane+Carboplatin (C/T/C)     Taxane+Carboplatin (T/C)  
STARTED     325 [1]   320 [2]
Never Treated     13 [3]   18 [4]
COMPLETED     320 [5]   320 [5]
NOT COMPLETED     5     0  
Still on study                 5                 0  
[1] 338 randomized and 325 treated.
[2] 338 randomized and 320 treated.
[3] Number by randomized group = 11, but 2 participants received C/T/C instead of T/C.
[4] Number by randomized group = 20, but 2 participants received C/T/C instead of T/C.
[5] Off all study therapies.



  Baseline Characteristics
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Reporting Groups
  Description
Cetuximab+Taxane+Carboplatin (C/T/C) Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
Taxane+Carboplatin (T/C) A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
Total Total of all reporting groups

Baseline Measures
    Cetuximab+Taxane+Carboplatin (C/T/C)     Taxane+Carboplatin (T/C)     Total  
Number of Participants  
[units: participants]
 		  338     338     676  
Age  
[units: years]
Mean ± Standard Deviation 		  64.0  ± 10.0     63.9  ± 10.3     64.0  ± 10.2  
Age, Customized  
[units: participants]
 		     
<65 years     171     165     336  
>= 65 years     167     173     340  
Gender  
[units: participants]
 		     
Female     146     134     280  
Male     192     204     396  
Race/Ethnicity, Customized [1]
[units: Participants]
 		     
Asian     6     10     16  
Black     25     24     49  
White     296     300     596  
Other race     11     4     15  
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [2]
[units: Participants]
 		     
0=fully active     110     114     224  
1=restricted physically strenuous activity     221     220     441  
2=ambulatory but unable to work     4     2     6  
3=capable of only limited self care     0     1     1  
4=completely disabled     0     0     0  
5=dead     0     0     0  
Missing     3     1     4  
Weight [3]
[units: kg]
Mean ± Standard Deviation 		  75.0  ± 17.1     75.3  ± 18.1     75.1  ± 17.6  
[1] 'Other race' includes 1 American Indian or Alaska native and 3 native Hawaiian or other pacific islander.
[2] The ECOG PS is used to assess disease severity. A score of 0 is fully active; 1 is restricted physically strenuous activity; 2 is ambulatory but unable to work; 3 is capable of only limited self care; 4 is completely disabled; 5 is dead. Missing includes participants whose pre-treatment PS > 14 days prior to first dose.
[3] 3 participants in the C/T/C group did not have values for this measure. 1 participant in the C/T group did not have a value for this measure.



  Outcome Measures
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1.  Primary:   Median Number of Months of Progression-free Survival (PFS)   [ Time Frame: From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months). ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Complete Response (CR) or Partial Response (PR)   [ Time Frame: From randomization to end of study drug therapy (up to 174 weeks). ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)   [ Time Frame: From randomization to end of study drug therapy (up to 174 weeks). ]
  Show Outcome Measure 3

4.  Secondary:   Median Number of Months of Response   [ Time Frame: Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months). ]
  Show Outcome Measure 4

5.  Secondary:   Median Number of Months to Response   [ Time Frame: Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months). ]
  Show Outcome Measure 5

6.  Secondary:   Median Number of Months of Survival   [ Time Frame: From randomization to death or date of last contact (up to 41 months). ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Improvement of Symptoms   [ Time Frame: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks). ]
  Show Outcome Measure 7

8.  Secondary:   Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)   [ Time Frame: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks). ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants Experiencing AEs Leading to Study Drug Discontinuation   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
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11.  Secondary:   Number of Participants Experiencing Other Significant AEs: Acneform Rash   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants Experiencing Other Significant AEs: Infusion Reaction   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
  Show Outcome Measure 12

13.  Secondary:   Number of Participants Experiencing Other Significant AEs: Cardiac AEs   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
  Show Outcome Measure 13

14.  Secondary:   Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
  Show Outcome Measure 14

15.  Secondary:   Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants   [ Time Frame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks). ]
  Show Outcome Measure 15

16.  Secondary:   Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures   [ Time Frame: Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation). ]
  Show Outcome Measure 16

17.  Other Pre-specified:   Median Change From Baseline in Symptoms, by Time Point   [ Time Frame: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks). ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: ClinicalTrials@bms.com


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00112294     History of Changes
Other Study ID Numbers: CA225-099
Study First Received: June 1, 2005
Results First Received: June 30, 2010
Last Updated: February 28, 2011
Health Authority: United States: Food and Drug Administration