Clinical trial NCT00095836: Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
Official title: A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
name: AstraZeneca
First posted: 2004-11-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed thyroid cancer, metastatic or locally advanced, not amenable or refractory to local therapy and/or radioactive iodine, depending on the cell type.
2. Thyroid cancer that is unresponsive or refractory to radioactive iodine. All medullary and anaplastic thyroid carcinomas will be considered unresponsive on the basis of histopathologic diagnosis alone. Well-differentiated thyroid cancers (papillary and follicular) will be considered refractory if either there is no evidence of uptake on radioactive iodine scanning or tumor growth persists in spite of treatment with radioactive iodine.
3. Measurable disease.
4. Patient is at least 18 years of age.
5. Eastern Cooperative Oncology Group performance status of 0-2.
6. If female and of reproductive potential, a negative β-HCG (human chorionic gonadotropin) and use of effective birth control for the course of the study.
7. Patient is capable of providing signed, informed consent.

Exclusion Criteria:

1. Concurrent chemotherapy, concurrent systemic anticancer treatment, or concurrent radiation therapy. Patients will not be excluded from the study on the basis of prior radiation therapy.
2. Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
3. Currently pregnant or nursing.
4. Absolute neutrophil count \<1.5 × 109/L, platelet count \< 75 × 109/L, bilirubin \> 1.5 × normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × normal.
5. Serum creatinine greater than Common Toxicity Criteria (CTC) grade 2.
6. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, St John's Wort.
7. Concomitant use of systemic retinoids, cyclosporine, verapamil, diltiazem, nicardipine, nifedipine, nitrendipine, erythromycin, theophylline, ketoconazole, itraconazole, and antihistamines such as terfenadine and astemizole.
8. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
9. Incomplete healing from previous oncologic or other major surgery.
10. Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease

    (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
12. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
13. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)

Primary outcomes:
measure: Objective Tumor Response Rate at 3, 6, and 12 Months
timeFrame: 3 Months, 6 Months, 1 Year
Secondary outcomes:
measure: Toxicity
timeFrame: Through study completion, on average 12 months
measure: Median Progression-free Survival
timeFrame: From the time of enrollment until disease progression or death, whichever came first
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John R Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1089/thy.2007.0120.