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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095836
• Other study ID #: 02-220
• Secondary ID: P30CA006516ZENEC
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: November 3, 2016
• Start date: March 2003
• Est. completion date: March 2011

Study information

• Verified date: November 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed thyroid cancer

• Metastatic or locally advanced disease

• Not amenable to OR unresponsive or refractory to local therapy and/or radioactive iodine, depending on cell type

• Medullary and anaplastic thyroid carcinomas are considered unresponsive on the basis of histology alone

• Well-differentiated papillary or follicular thyroid carcinomas are considered refractory if there is no evidence of uptake on radioactive iodine scanning OR the tumor progresses despite treatment with radioactive iodine

• Measurable disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 75,000/mm^3

Hepatic

• AST or ALT = 3 times normal

• Bilirubin = 1.5 times normal

• No unstable or uncompensated hepatic disease

Renal

• Creatinine = Common Toxicity Criteria grade 2

• No unstable or uncompensated renal disease

Cardiovascular

• No unstable or uncompensated cardiac disease

Pulmonary

• No clinically active interstitial lung disease

• Chronic, stable, asymptomatic radiographic changes allowed

• No unstable or uncompensated respiratory disease

Other

• No known severe hypersensitivity to gefitinib or any of its excipients

• No other severe or uncontrolled systemic disease

• No other significant clinical disorder or laboratory finding that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No concurrent local-regional radiotherapy to a primary disease site

• No concurrent radiotherapy to a bony or CNS metastasis

Surgery

• Completely healed after prior oncologic or other major surgery

Other

• Recovered from all prior anticancer therapy

• More than 30 days since prior non-approved or investigational drugs

• No concurrent use of any of the following agents:

• Phenytoin

• Carbamazepine

• Barbiturates

• Rifampin

• Phenobarbital

• Hypericum perforatum (St. John's wort)

• Systemic retinoids

• Cyclosporine

• Verapamil

• Diltiazem

• Nicardipine

• Nifedipine

• Nitrendipine

• Erythromycin

• Theophylline

• Ketoconazole

• Itraconazole

• Antihistamines (e.g., terfenadine or astemizole)

• No concurrent grapefruit or grapefruit juice

• No other concurrent systemic anticancer treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• gefitinib
Taken orally once a day

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AstraZeneca, Brigham and Women's Hospital, Dana-Farber Cancer Institute, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pennell NA, Daniels GH, Haddad RI, Ross DS, Evans T, Wirth LJ, Fidias PH, Temel JS, Gurubhagavatula S, Heist RS, Clark JR, Lynch TJ. A phase II study of gefitinib in patients with advanced thyroid cancer. Thyroid. 2008 Mar;18(3):317-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as assessed by RECIST criteria every 2 months		Every 2 months	No
Secondary	Toxicity as assessed by NCI CTC monthly		Every cycle	Yes
Secondary	Progression-free survival as assessed by RECIST criteria every 2 months		Every 2 months	No
Secondary	Overall survival		5 years	No