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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate as assessed by RECIST criteria every 2 months

Outcome Time Frame:

Every 2 months

Safety Issue:

No

Principal Investigator

John R Clark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

02-220

NCT ID:

NCT00095836

Start Date:

March 2003

Completion Date:

March 2011

Related Keywords:

  • Head and Neck Cancer
  • recurrent thyroid cancer
  • stage III follicular thyroid cancer
  • stage III papillary thyroid cancer
  • stage IV follicular thyroid cancer
  • stage IV papillary thyroid cancer
  • anaplastic thyroid cancer
  • thyroid gland medullary carcinoma
  • Thyroid Neoplasms
  • Head and Neck Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115