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
4 other identifiers
interventional
27
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 head-and-neck-cancer
Started Mar 2003
Longer than P75 for phase_2 head-and-neck-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
May 31, 2017
CompletedMay 31, 2017
May 1, 2017
8 years
November 9, 2004
March 1, 2017
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Tumor Response Rate at 3, 6, and 12 Months
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
3 Months, 6 Months, 1 Year
Secondary Outcomes (3)
Toxicity
Through study completion, on average 12 months
Median Progression-free Survival
From the time of enrollment until disease progression or death, whichever came first
Overall Survival
5 years
Study Arms (1)
Gefitinib 250mg
EXPERIMENTALInterventions
Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- Measurable disease.
- Patient is at least 18 years of age.
- Eastern Cooperative Oncology Group performance status of 0-2.
- 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.
- Patient is capable of providing signed, informed consent.
You may not qualify if:
- 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.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
- Currently pregnant or nursing.
- 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.
- Serum creatinine greater than Common Toxicity Criteria (CTC) grade 2.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, St John's Wort.
- Concomitant use of systemic retinoids, cyclosporine, verapamil, diltiazem, nicardipine, nifedipine, nitrendipine, erythromycin, theophylline, ketoconazole, itraconazole, and antihistamines such as terfenadine and astemizole.
- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
- Incomplete healing from previous oncologic or other major surgery.
- Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease
- (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
- Dana-Farber Cancer Institutecollaborator
- Brigham and Women's Hospitalcollaborator
- AstraZenecacollaborator
Study Sites (2)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related 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. doi: 10.1089/thy.2007.0120.
PMID: 17985985RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Clark, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
John R Clark, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 9, 2004
Study Start
March 1, 2003
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
May 31, 2017
Results First Posted
May 31, 2017
Record last verified: 2017-05