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

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. Identifier: NCT00095836
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
John Ross Clark, Massachusetts General Hospital

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

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
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
Lost to Follow-up                1 
Adverse Event                1 
Death                2 

  Baseline Characteristics

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
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]
[Units: Participants]
Count of Participants
Participants Analyzed   27 
<=18 years      0   0.0% 
Between 18 and 65 years      14  51.9% 
>=65 years      13  48.1% 
[Units: Years]
Mean (Standard Deviation)
Participants Analyzed   27 
   64.5  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Participants Analyzed   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   27 
United States   27 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
Participants Analyzed   27 
0-1   25 
Participants Analyzed   27 

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)
[Units: Participants]
Count of Participants
Locally Advanced   
Participants Analyzed   27 
Locally Advanced   2 
Participants Analyzed   27 
Metastatic   25 
Metastatic sites [1] 
[Units: Participants]
Count of Participants
Participants Analyzed   25 
Lung-only   10 
Lung + extra-pulmonary metastases   
Participants Analyzed   25 
Lung + extra-pulmonary metastases   15 
[1] Participants with metastatic cancer
Prior therapy 
[Units: Participants]
Radioactive iodine   
Participants Analyzed   27 
Radioactive iodine   17 
Participants Analyzed   27 
Chemotherapy   6 
External beam radiotherapy   
Participants Analyzed   27 
External beam radiotherapy   23 
[Units: Participants]
Count of Participants
Participants Analyzed   27 
Papillary   11 
Participants Analyzed   27 
Follicular   6 
Participants Analyzed   27 
Anaplastic   5 
Participants Analyzed   27 
Medullary   4 
Hürthle cell   
Participants Analyzed   27 
Hürthle cell   1 

  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

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

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

Publications of Results:

Responsible Party: John Ross Clark, Massachusetts General Hospital 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