Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
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|ClinicalTrials.gov Identifier: NCT00095836|
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Gefitinib||Phase 2|
- Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib.
- Determine the toxicity of this drug in these patients.
- Determine progression-free and overall survival of patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer|
|Actual Study Start Date :||March 2003|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
|Experimental: Gefitinib 250mg||
Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
- Objective Tumor Response Rate at 3, 6, and 12 Months [ Time Frame: 3 Months, 6 Months, 1 Year ]
Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year.
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
- Toxicity [ Time Frame: Through study completion, on average 12 months ]Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients
- Median Progression-free Survival [ Time Frame: From the time of enrollment until disease progression or death, whichever came first ]
The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions.
- Overall Survival [ Time Frame: 5 years ]The median overall survival time, measured from the time of enrollment until death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095836
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||John R Clark, MD||Massachusetts General Hospital|