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Trial record 1 of 1 for:    01081041
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A Study in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01081041
First received: March 3, 2010
Last updated: October 13, 2014
Last verified: October 2014
Results First Received: June 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: Cetuximab
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-Fluorouracil

  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
Two-part study: Part 1 (single arm, safety lead-in) then Part 2 (parallel treatment comparison). All participants to complete 6 cycles of combination therapy then, if eligible, monotherapy. Participant flow presents those who completed study (died); those who were alive or death status unknown at data cut-off considered to not have completed study.

Reporting Groups
  Description
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)

Combination Therapy (maximum 6 cycles):

  • United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
  • Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
  • 5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.

Monotherapy Therapy:

Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU

Combination Therapy (maximum 6 cycles):

  • US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
  • Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
  • 5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.

Monotherapy Therapy:

Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU

Combination Therapy (maximum 6 cycles):

  • Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
  • Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
  • 5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.

Monotherapy Therapy:

Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.


Participant Flow:   Overall Study
    Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)     Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU     Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU  
STARTED     33     81 [1]   73 [1]
Started Combination Therapy     33 [2]   77 [2]   71 [2]
Started Monotherapy     7     33     40  
COMPLETED     27     51     50  
NOT COMPLETED     6     30     23  
On study                 6                 30                 23  
[1] Enrollment in Part 2 of study started after enrollment completed in Part 1.
[2] Participants who started combination therapy received at least 1 dose of any study drug.



  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.
Participants who received at least 1 dose of any study drug (cetuximab, cisplatin, carboplatin, or 5-FU).

Reporting Groups
  Description
Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)

Combination Therapy (maximum 6 cycles):

  • US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
  • Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
  • 5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.

Monotherapy Therapy:

Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU

Combination Therapy (maximum 6 cycles):

  • US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
  • Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
  • 5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.

Monotherapy Therapy:

Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU

Combination Therapy (maximum 6 cycles):

  • Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.
  • Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.
  • 5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.

Monotherapy Therapy:

Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Total Total of all reporting groups

Baseline Measures
    Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)     Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU     Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU     Total  
Number of Participants  
[units: participants]
  33     77     71     181  
Age [1]
[units: years]
Mean ± Standard Deviation
  62.9  ± 8.74     57.1  ± 10.75     59.4  ± 10.49     59.0  ± 10.47  
Gender, Customized  
[units: participants]
       
Female     11     9     15     35  
Male     22     68     55     145  
Unknown or Not Reported     0     0     1     1  
Race/Ethnicity, Customized  
[units: participants]
       
American Indian or Alaska Native     2     16     9     27  
Asian     0     1     2     3  
Black or African American     2     7     2     11  
White     29     53     56     138  
More than 1 race     0     0     1     1  
Unknown or Not Reported     0     0     1     1  
Region of Enrollment [2]
[units: participants]
       
United States     27     25     28     80  
Mexico     1     23     15     39  
Canada     5     29     27     61  
Disease Stage at Study Entry  
[units: participants]
       
Locoregional     6     34     32     72  
Metastatic     27     43     38     108  
Unknown or not reported     0     0     1     1  
Karnofsky Performance Status (KPS) [3]
[units: participants]
       
KPS 70     5     9     7     21  
KPS 80     19     28     22     69  
KPS 90     5     32     31     68  
KPS 100     4     8     11     23  
[1] Age not available for 1 participant in the cetuximab manufactured by BI reporting group; N=70.
[2] Region of enrollment not available for 1 participant in the cetuximab manufactured by BI reporting group; N=70.
[3] The KPS rates the performance status and neurological functioning of a participant on a scale from KPS 0 (Dead) to KPS 100 (No complaints; no evidence of disease) in increments of 10. KPS 90 (Able to carry on normal activity; minor signs or symptoms of disease), KPS 80 (Normal activity with effort; some signs or symptoms of disease), and KPS 70 (Cares for self; unable to carry on normal activity or do active work).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013   [ Time Frame: Part 2: Baseline to end of combination therapy (up to 18 weeks) ]

2.  Primary:   Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013   [ Time Frame: Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks) ]

3.  Secondary:   Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m^2 Cetuximab Dosing   [ Time Frame: Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose ]

4.  Secondary:   Cmax of Cetuximab at Steady State   [ Time Frame: Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose ]

5.  Secondary:   Area Under the Concentration Curve (AUC) of Cetuximab at Steady State   [ Time Frame: Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Parts 1 and 2: Randomization to date of death from any cause ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No

7.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Parts 1 and 2: Randomization to the first date of objective progression of disease or death from any cause ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No

8.  Secondary:   Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR)   [ Time Frame: Parts 1 and 2: Randomization to progression of disease ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No

9.  Secondary:   Anti-Cetuximab Antibodies   [ Time Frame: Parts 1 and 2: Day 1 of Week 1 in Cycles 1, 3, and 5, and 30 days post treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No

10.  Secondary:   Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD)   [ Time Frame: Parts 1 and 2: Randomization to progression of disease ]
Results not yet reported.   Anticipated Reporting Date:   09/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Unless specified otherwise, the entire record reports results using a September 27, 2013 data cut-off. This is the date the last data was collected for analysis of primary measure.


  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: NCT01081041     History of Changes
Other Study ID Numbers: 13611, I4E-MC-JXBD
Study First Received: March 3, 2010
Results First Received: June 12, 2014
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ethics Committee
Mexico: Ministry of Health