Head and Neck CancerPhase 2NCT00095836
Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
A Phase 2 study testing Gefitinib in people with Head and Neck Cancer, run by Massachusetts General Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2003to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Gefitinib
- 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
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary, Thyroid Carcinoma, Anaplastic, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called ZD1839, IRESSA
Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib 250mg | Experimental | Not described Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Months, 6 Months, 1 Year
Secondary outcomes (3)
Toxicity
Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients
Measured: Through study completion, on average 12 months
Median Progression-free Survival
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.
Measured: From the time of enrollment until disease progression or death, whichever came first
Overall Survival
The median overall survival time, measured from the time of enrollment until death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startMar 2003
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber Cancer Institute, Brigham and Women's Hospital, AstraZeneca
- Responsible party
- Principal investigator, John Ross Clark, Massachusetts General Hospital
- Investigators
- John R Clark, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095836
- Sponsor's protocol ID
- 02-220
- Other IDs
- P30CA006516, ZENECA-IRUSIRES0165, CDR0000393510
- Status last verified
- May 2017
- First submitted
- 9 Nov 2004
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17985985
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ZD 1839 (IRESSA®) in Patients With Advanced Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00095836
- Acronym / sponsor ID
- 02-220
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber Cancer Institute, Brigham and Women's Hospital, AstraZeneca
- Study start
- Mar 2003 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib 250mg | Experimental | Drug: Gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefitinibAlso: ZD1839, IRESSATaken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity. | Drug | Gefitinib 250mg |
Primary outcome
Objective Tumor Response Rate at 3, 6, and 12 Months
Time frame: 3 Months, 6 Months, 1 Year
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 secondary outcomes
Toxicity
Time frame: Through study completion, on average 12 months
Median Progression-free Survival
Time frame: From the time of enrollment until disease progression or death, whichever came first
Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17985985Pennell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Clark, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib in people with Head and Neck Cancer, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Tumor Response Rate at 3, 6, and 12 Months (time frame: 3 Months, 6 Months, 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00095836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.