A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00371566
First received: August 31, 2006
Last updated: April 1, 2010
Last verified: April 2010
Results First Received: December 26, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma of Head and Neck
Interventions: Drug: Lapatinib oral tablets
Drug: Placebo

  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
Placebo Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
Lapatinib Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).

Participant Flow for 3 periods

Period 1:   Treatment Phase
    Placebo     Lapatinib  
STARTED     36     71  
COMPLETED     36     68 [1]
NOT COMPLETED     0     3  
Withdrawal by Subject                 0                 1  
Adverse Event                 0                 1  
Protocol Violation                 0                 1  
[1] 1 screen failure included in the ITT population

Period 2:   Chemoradiation Phase
    Placebo     Lapatinib  
STARTED     36     68  
COMPLETED     31     65  
NOT COMPLETED     5     3  
Physician Decision                 2                 0  
Withdrawal by Subject                 0                 1  
Non compliant                 0                 1  
Progressive Disease                 1                 1  
Death                 2                 0  

Period 3:   Follow Up Phase
    Placebo     Lapatinib  
STARTED     31     65  
COMPLETED     28     58  
NOT COMPLETED     3     7  
Death                 0                 5  
Disease progression                 1                 0  
Withdrawal by Subject                 0                 1  
Physician Decision                 1                 1  
Lost to Follow-up                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Placebo Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
Lapatinib Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
Total Total of all reporting groups

Baseline Measures
    Placebo     Lapatinib     Total  
Number of Participants  
[units: participants]
  36     71     107  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 10.47     57.7  ± 11.01     57.1  ± 10.83  
Gender  
[units: participants]
     
Female     4     16     20  
Male     32     55     87  
Race/Ethnicity, Customized  
[units: participants]
     
White     21     39     60  
African American     0     0     0  
American Indian or Alaska Native     3     11     14  
Asian-Central and South Asian Heritage     9     19     28  
Asian-Japanese East/South east Heritage     2     2     4  
Asian-Mixed Heritage     1     0     1  
Native Hawaiian or Pacific Islander     0     0     0  



  Outcome Measures
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1.  Primary:   Change From Baseline of the Apoptotic Index During Treatment Phase   [ Time Frame: Baseline and Week 2 ]

2.  Secondary:   Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase   [ Time Frame: Baseline and Week 2 ]

3.  Secondary:   Overall Radiological Response After Treatment Phase in mITT Population   [ Time Frame: Baseline and End of Treatment (Week 2 - 6) ]

4.  Secondary:   Overall Radiological Response After Follow-up Phase in mITT Population   [ Time Frame: Baseline and End of Follow-up (Week 19 - 25) ]

5.  Secondary:   Overall Radiological Response After Treatment Phase in ITT Population   [ Time Frame: Baseline and End of Treatment (Week 2 - 6) ]

6.  Secondary:   Overall Radiological Response After Follow-up Phase in ITT Population   [ Time Frame: Baseline and End of Follow-up (week 19 - 25) ]

7.  Secondary:   Number of Circulating Tumor Cells at Baseline in mITT Population   [ Time Frame: Baseline ]

8.  Secondary:   Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population   [ Time Frame: End of Treatment (week 2 - 6) ]

9.  Secondary:   Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population   [ Time Frame: End of Chemoradiotherapy (week 10 - 13) ]

10.  Secondary:   Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase   [ Time Frame: Baseline and Week 2 ]

11.  Secondary:   Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase   [ Time Frame: Week 2 ]

12.  Secondary:   Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase   [ Time Frame: Week 1 through Week 6 ]

13.  Secondary:   Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase   [ Time Frame: Week 10 through 25 ]

14.  Secondary:   Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information   [ Time Frame: Week 2 - 4 ]

15.  Secondary:   Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information   [ Time Frame: weeks 19 - 25 ]

16.  Secondary:   Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group   [ Time Frame: Week 1 through 25 ]

17.  Secondary:   Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase   [ Time Frame: Week 10 through 25 ]

18.  Secondary:   Summary of Serious Adverse Events During or After Chemoradiotherapy Phase   [ Time Frame: Week 10 through 25 ]

19.  Secondary:   Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase   [ Time Frame: Week 10 through 25 ]

20.  Secondary:   Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase   [ Time Frame: Week 10 through 25 ]

21.  Secondary:   Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase   [ Time Frame: Week 10 through 25 ]

22.  Secondary:   Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

23.  Secondary:   Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

24.  Secondary:   Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

25.  Secondary:   Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

26.  Secondary:   Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

27.  Secondary:   Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

28.  Secondary:   Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

29.  Secondary:   Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

30.  Secondary:   Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

31.  Secondary:   Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

32.  Secondary:   Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]

33.  Secondary:   Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment   [ Time Frame: Baseline, and Week 2 - 4 ]


  Serious Adverse Events


  Other Adverse Events


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00371566     History of Changes
Other Study ID Numbers: EGF104334
Study First Received: August 31, 2006
Results First Received: December 26, 2008
Last Updated: April 1, 2010
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines