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IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00229723
First received: September 28, 2005
Last updated: June 17, 2009
Last verified: June 2009
History of Changes
Results First Received: June 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Neoplasms, Squamous Cell
Interventions: Drug: gefitinib (Iressa)
Drug: cisplatin
Radiation: radiotherapy
Drug: Gefitinib (Iressa)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In total, 226 patients from 26 centres in 8 countries were randomized to receive study medication, the first patient was enrolled into the study on 13 November 2004 and the last patient completed the study on 27 June 2008. Patients were to be followed up for a maximum of two years (± 12 weeks) after randomization.

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/Placebo Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
250mg/Placebo Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
500mg/Placebo Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
250mg/250mg Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
500mg/500mg Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Placebo/250mg Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
Placebo/500mg Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy

Participant Flow for 2 periods

 Period 1:   Concomitant Phase
    Placebo/Placebo     250mg/Placebo     500mg/Placebo     250mg/250mg     500mg/500mg     Placebo/250mg     Placebo/500mg  
STARTED     60 [1]   24 [1]   31 [1]   31 [1]   24 [1]   34 [1]   22 [1]
COMPLETED     50     19     25     26     22     31     19  
NOT COMPLETED     10     5     6     5     2     3     3  
Adverse Event                 4                 2                 5                 2                 0                 1                 2  
Objective disease progression                 0                 0                 0                 0                 0                 0                 0  
Clinical progression                 0                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 1                 0                 0  
Informed consent withdrawn                 3                 2                 0                 2                 0                 0                 0  
Severe non-compliance                 0                 1                 0                 0                 1                 0                 0  
Unspecified                 3                 0                 1                 1                 0                 2                 0  
[1] Received randomized treatment

Period 2:   Maintenance Phase
    Placebo/Placebo     250mg/Placebo     500mg/Placebo     250mg/250mg     500mg/500mg     Placebo/250mg     Placebo/500mg  
STARTED     50     19     25     26     22     31     19  
COMPLETED     25 [1]   5 [1]   16 [1]   9 [1]   7 [1]   12 [1]   9 [1]
NOT COMPLETED     25     14     9     17     15     19     10  
Adverse Event                 7                 2                 1                 4                 7                 5                 2  
Objective disease progression                 5                 5                 3                 6                 2                 9                 5  
Clinical progression                 4                 1                 2                 2                 1                 1                 1  
Lost to Follow-up                 0                 1                 2                 2                 0                 0                 1  
Informed consent withdrawn                 1                 0                 0                 1                 1                 1                 0  
Severe non-compliance                 3                 1                 0                 0                 1                 0                 0  
Unspecified                 5                 4                 1                 2                 3                 3                 1  
[1] Completed study on randomized treatment



  Baseline Characteristics
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Reporting Groups
  Description
Placebo/Placebo Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
250mg/Placebo Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
500mg/Placebo Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
250mg/250mg Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
500mg/500mg Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Placebo/250mg Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
Placebo/500mg Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Total Total of all reporting groups

Baseline Measures
    Placebo/Placebo     250mg/Placebo     500mg/Placebo     250mg/250mg     500mg/500mg     Placebo/250mg     Placebo/500mg     Total  
Number of Participants  
[units: participants]
 		  60     24     31     31     24     34     22     226  
Age  
[units: Years]
Mean ( Full Range ) 		  53.1  
  ( 29 to 67 )   		  52.5  
  ( 21 to 73 )   		  53.4  
  ( 30 to 74 )   		  54.3  
  ( 33 to 69 )   		  50.8  
  ( 33 to 72 )   		  53.4  
  ( 45 to 70 )   		  54.9  
  ( 31 to 73 )   		  53.2  
  ( 21 to 74 )  
Gender  
[units: Participants]
 		               
Female     8     3     3     4     5     1     4     28  
Male     52     21     28     27     19     33     18     198  
Race/Ethnicity, Customized  
[units: Participants]
 		               
Caucasian (includes Indian)     56     22     29     29     22     32     20     210  
Oriental     4     2     2     2     2     2     2     16  
Original site of primary cancer  
[units: Participants]
 		               
Oral cavity     4     0     2     1     3     2     3     15  
Oropharynx     26     12     15     18     13     15     10     109  
Hypopharynx     19     9     9     10     4     12     4     67  
Larynx     10     2     4     1     3     4     3     27  
Oropharynx / Hypopharynx     0     0     0     1     0     0     0     1  
Other     1     1     1     0     1     1     2     7  
Stage of disease at entry to study  
[units: Participants]
 		               
Stage III     10     7     7     7     4     6     8     49  
Stage IV (All these patients had Stage IVa cancer)     50     17     24     24     20     28     14     177  
WHO Performance Status  
[units: Participants]
 		               
0 (Normal activity)     41     14     24     24     17     24     16     160  
1 (Restricted activity)     13     8     6     4     6     6     5     48  
2 (in bed ≤ 50% of the time)     0     0     0     0     0     0     0     0  
3 (in bed > 50% of the time)     0     0     0     0     0     0     0     0  
4 (100% Bed ridden)     0     0     0     0     0     0     0     0  
Not recorded     6     2     1     3     1     4     1     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Local Disease Control Rate at 2 Years   [ Time Frame: Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)). ]
  Show Outcome Measure 1

2.  Secondary:   Local Disease Control Rate at 1 Year   [ Time Frame: Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST). ]
  Show Outcome Measure 2

3.  Secondary:   Complete Response   [ Time Frame: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression. ]
  Show Outcome Measure 3

4.  Secondary:   Tumour Response (Complete Response + Partial Response)   [ Time Frame: Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression ]
  Show Outcome Measure 4

5.  Secondary:   Progression Free Survival   [ Time Frame: Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST) ]
  Show Outcome Measure 5

6.  Secondary:   Overall Survival   [ Time Frame: Overall survival assessed at 2 years ]
  Show Outcome Measure 6

7.  Secondary:   Safety and Tolerability   [ Time Frame: Assessed over two years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Gerard Lynch
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided


ClinicalTrials.gov Identifier: NCT00229723     History of Changes
Obsolete Identifiers: NCT00099398
Other Study ID Numbers: 1839IL/0706, EudraCT number 2004-000358-21, D7919C00706
Study First Received: September 28, 2005
Results First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: United States: Food and Drug Administration