A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01087970
First received: March 15, 2010
Last updated: April 18, 2014
Last verified: April 2014
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Neoplasms
Interventions: Drug: Pemetrexed
Drug: Cetuximab
Drug: Carboplatin
Drug: Cisplatin

  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
Cetuximab + Pemetrexed + Carboplatin/Cisplatin

Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.


Participant Flow:   Overall Study
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin  
STARTED     69  
Received ≥1 Dose of Any Study Drug     69  
Completed 6 Cycles     69  
Efficacy Population     58 [1]
Received Carboplatin     63  
COMPLETED     67  
NOT COMPLETED     2  
Protocol Violation                 2  
[1] All treated participants excluding those from a noncompliant study site.



  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.
All enrolled participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Cetuximab + Pemetrexed + Carboplatin/Cisplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.


Baseline Measures
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin  
Number of Participants  
[units: participants]
  69  
Age  
[units: years]
Mean ± Standard Deviation
  61.9  ± 10.3  
Gender  
[units: participants]
 
Female     12  
Male     57  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     5  
Not Hispanic or Latino     63  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     11  
White     56  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     69  
European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) [1]
[units: units on a scale]
Mean ± Standard Deviation
 
Index Score (n=47)     0.721  ± 0.248  
Visual Analog Scale (VAS) Score (n=47)     66.106  ± 20.658  
Performance Status Scale for Head and Neck Cancer (PSS-HNC) [2]
[units: units on a scale]
Mean ± Standard Deviation
 
NOD (n=57)     56.32  ± 37.87  
UOS (n=57)     78.51  ± 32.20  
EIP (n=57)     71.93  ± 34.42  
[1] Participants assessed health-related QoL in 5 D (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as no problems/some or moderate problems/extreme problems. A regression equation defines a utility value for these health states to generate an index score from -0.594 (severe problems in all 5 D) to 1 (no problem in all 5 D) where 1=best possible health state. EQ-5D VAS rates participant's current health-related QoL on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
[2] Clinician measured speaking and eating disabilities of HNC participants that consists 3 subscales: normalcy of diet (NOD) measures ability of eating a normal diet, scale from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) measures the degree a clinician was able to understand participant's speech, scale from 0 (never understandable) to 100 (always understandable); eating in public (EIP) is based on clinician’s question to the participant, scale from 0 (always eats alone) to 100 (no restriction of place, food, or companion).



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months) ]

3.  Secondary:   Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)   [ Time Frame: From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease) ]

4.  Secondary:   Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)   [ Time Frame: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle) ]

5.  Secondary:   Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)   [ Time Frame: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle) ]

6.  Other Pre-specified:   Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)   [ Time Frame: From enrollment to 30 days post-treatment discontinuation up to 26.4 months ]


  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
Efficacy populations excluded data from a noncompliant site (11 participants).


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01087970     History of Changes
Other Study ID Numbers: 13491, H3E-MC-S132
Study First Received: March 15, 2010
Results First Received: April 18, 2014
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration