Symptoms and General Pathology

All Conditions

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Head and Neck Neoplasms

Adenocarcinoma, Follicular

Thyroid Carcinoma, Anaplastic

Carcinoma, Medullary

Endocrine System Diseases

Endocrine Gland Neoplasms

Papillary Thyroid Carcinoma

Thyroid Cancer, Follicular

Anaplastic Thyroid Cancer

Thyroid Cancer, Medullary

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Iodine

Gefitinib

Cadexomer iodine

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

John R Clark, MD

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.

OBJECTIVES:

Primary

* Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib.

Secondary

* 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.

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

A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer

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

Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients

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.

The median overall survival time, measured from the time of enrollment until death.

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Brigham and Women's Hospital

AstraZeneca

Massachusetts General Hospital

Physician

During routine visits subjects will be assessed for toxicity using physical examination and laboratory tests. Assessments are performed every 4 weeks while on treatment. If a participant has experienced no grade 3 or 4 toxicity for a 6-month time period, toxicity may be assessed every 2 months. If If the patient continues to do well after 2 years, assessment may be extended to every 3 months.

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

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.

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

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)

ECOG Performance Status

Locally Advanced

Metastatic

Stage

Lung-only

Lung + extra-pulmonary metastases

Metastatic sites

Radioactive iodine

Chemotherapy

External beam radiotherapy

Prior therapy

Papillary

Follicular

Anaplastic

Medullary

Hürthle cell

Histology

John Clark, MD

Complete Response : 3 Months

Partial Response : 3 Months

Stable Disease : 3 Months

Progressive Disease : 3 Months

Complete Response : 6 Months

Partial Response : 6 Months

Stable Disease : 6 Months

Progressive Disease : 6 Months

Complete Response : 12 Months

Partial Response : 12 Months

Stable Disease : 12 Months

Progressive Disease : 12 Months

Two patients lost to follow-up prior to assessment of tumor response

Objective Tumor Response Rate at 3, 6, and 12 Months

Rash: Grade 0

Rash: Grade 1

Rash: Grade 2

Rash: Grade 3

Diarrhea: Grade 0

Diarrhea: Grade 1

Diarrhea: Grade 2

Diarrhea: Grade 3

Nausea: Grade 0

Nausea: Grade 1

Anorexia: Grade 0

Anorexia: Grade 1

Toxicity

Median Progression-free Survival

Overall Survival

Overall Study

Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial