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Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095836
First Posted: November 9, 2004
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
AstraZeneca
Information provided by (Responsible Party):
John Ross Clark, Massachusetts General Hospital
Results First Submitted: March 1, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Intervention: Drug: Gefitinib

  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
Patients were enrolled from Massachusetts General Hospital and the Dana-Farber Cancer Institute

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
Gefitinib 250mg gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Gefitinib 250mg
STARTED   27 
COMPLETED   23 
NOT COMPLETED   4 
Lost to Follow-up                1 
Adverse Event                1 
Death                2 



  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
Gefitinib 250mg Gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.

Baseline Measures
   Gefitinib 250mg 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 27 
<=18 years      0   0.0% 
Between 18 and 65 years      14  51.9% 
>=65 years      13  48.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 27 
   64.5  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 27 
Female      11  40.7% 
Male      16  59.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 27 
United States   27 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
 
0-1   
Participants Analyzed 
[Units: Participants]
 27 
0-1   25 
 
Participants Analyzed 
[Units: Participants]
 27 
 2 
[1]

Eastern Cooperative Oncology Group (ECOG) performance status.

0 – Asymptomatic (Fully active, able to carry on all predisease activities without restriction)

  1. – Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
  2. – Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
Stage 
[Units: Participants]
Count of Participants
 
Locally Advanced   
Participants Analyzed 
[Units: Participants]
 27 
Locally Advanced   2 
Metastatic   
Participants Analyzed 
[Units: Participants]
 27 
Metastatic   25 
Metastatic sites [1] 
[Units: Participants]
Count of Participants
 
Lung-only   
Participants Analyzed 
[Units: Participants]
 25 
Lung-only   10 
Lung + extra-pulmonary metastases   
Participants Analyzed 
[Units: Participants]
 25 
Lung + extra-pulmonary metastases   15 
[1] Participants with metastatic cancer
Prior therapy 
[Units: Participants]
 
Radioactive iodine   
Participants Analyzed 
[Units: Participants]
 27 
Radioactive iodine   17 
Chemotherapy   
Participants Analyzed 
[Units: Participants]
 27 
Chemotherapy   6 
External beam radiotherapy   
Participants Analyzed 
[Units: Participants]
 27 
External beam radiotherapy   23 
Histology 
[Units: Participants]
Count of Participants
 
Papillary   
Participants Analyzed 
[Units: Participants]
 27 
Papillary   11 
Follicular   
Participants Analyzed 
[Units: Participants]
 27 
Follicular   6 
Anaplastic   
Participants Analyzed 
[Units: Participants]
 27 
Anaplastic   5 
Medullary   
Participants Analyzed 
[Units: Participants]
 27 
Medullary   4 
Hürthle cell   
Participants Analyzed 
[Units: Participants]
 27 
Hürthle cell   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response Rate at 3, 6, and 12 Months   [ Time Frame: 3 Months, 6 Months, 1 Year ]

2.  Secondary:   Toxicity   [ Time Frame: Through study completion, on average 12 months ]

3.  Secondary:   Median Progression-free Survival   [ Time Frame: From the time of enrollment until disease progression or death, whichever came first ]

4.  Secondary:   Overall Survival   [ Time Frame: 5 years ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Clark, MD
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: jrclark@partners.org


Publications of Results:

Responsible Party: John Ross Clark, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00095836     History of Changes
Other Study ID Numbers: 02-220
P30CA006516 ( U.S. NIH Grant/Contract )
ZENECA-IRUSIRES0165 ( Other Identifier: AstraZeneca )
CDR0000393510 ( Registry Identifier: NCI PDQ )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: March 1, 2017
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017