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Papillary Thyroid CancerPhase 2IIT SutentNCT00668811

Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

A Phase 2 study testing SU011248, Sutent in people with Papillary Thyroid Cancer and Follicular Thyroid Cancer, run by Medstar Health Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SU011248, Sutent
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Apr 2008to Dec 2015
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

  • The study population will consist of men and women with histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (e.g., papillary or follicular thyroid cancer) that has been previously treated with at least one course of radioactive iodine therapy and has evidence of residual, recurrent or progressive disease documented by any combination of radiologic studies and thyroglobulin levels.
  • To be eligible for inclusion, patients must fulfill each of the following criteria:
  • Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Age >18 years.
  • Histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4 differentiated thyroid cancer (i.e., papillary or follicular thyroid cancer).
  • If a patient has distant metastases, it must be documented by any combination of radiographic studies or whole body radioiodine scanning.
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  • Previously treated with at least one course of radioactive iodine (I-131) therapy.
  • At least one measurable site of disease as defined by the Tumor Assessment Criteria in Appendix 3.
  • Serum thyroglobulin levels inappropriately elevated:
  • > 60 ng/mL with thyroid gland > 1 ng/mL without thyroid gland
  • ECOG performance status 0-2.
  • Life expectancy ≥ 3 months.
  • Normal organ function. The definitions of minimum adequacy for organ function required prior to study entry are as follows:
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy.
  • Total serum bilirubin less than or equal to 1.5 x ULN.
  • Serum albumin greater than or equal to 3.0 g/dL.
  • Absolute neutrophil count (ANC) greater than or equal to 1500/uL.
  • Platelets greater than or equal to 100,000/uL.
  • Hemoglobin greater than or equal to 9.0 g/dL
  • Serum creatinine less than or equal to 1.5 x ULN.
  • Agreement to use contraceptives for women with child bearing potential. Unless surgically sterile, men must agree to use effective contraception during period of therapy.
  • The patient must be aware of the nature of his or her malignancy, understand the protocol requirements, risks, discomforts, and be able and willing to sign an informed consent.

Who cannot join

  • Patients who fulfill any of the following criteria will be excluded:
  • Prior systemic chemotherapy or targeted therapy within 3 months prior to enrollment.
  • Prior treatment on a Sutent clinical trial or current treatment on another clinical trial.
  • Prior external beam radiation therapy to the target lesion(s).
  • Life expectancy < 3 months.
  • History of any other carcinomas within the last 5 years, except cured basal cell carcinoma of the skin and cured in-situ cervical cancer.
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  • Serious uncontrolled concomitant disease that the Investigator feels might compromise study participation.
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or the inability to take oral medication.
  • Any of the following clinical conditions within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, pulmonary embolism, ongoing cardiac dysrhythmias of NCI CTCAE grade at least 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
  • Uncontrollable hypertension.
  • Known human immunodeficiency virus infection.
  • Current treatment with therapeutic doses of Coumadin-derivative anticoagulants (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Patients with a history of uncontrolled seizures, central nervous system disorders of psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from study.
  • Inability to swallow whole tablets.
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed.

This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.

Read the detailed description

This is a two-stage, phase II, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

Being tested
SU011248, Sutent
Keywords
thyroid cancer, metastatic thyroid cancer, differentiated thyroid cancer, papillary thyroid cancer, follicular thyroid cancer, Histologically confirmed, metastatic stage 2,stage 3, or stage 4 differentiated thyroid cancer
Medical subject headings
Thyroid Cancer, Papillary, Adenocarcinoma, Follicular, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SU011248, SutentDrug

    Also called Sunitinib

    Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.

Study groups in NCT00668811
Study groupRoleWhat they receive
Treatment Arm - SutentExperimentalSutent 37.5 mg/day will be given orally.
Receives: Drug: SU011248, Sutent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    Measured: 12 months after last patient completes treatment

Secondary outcomes (1)

  1. Overall Survival

    Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.

    Measured: 12 months after last patient completes treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionSep 2015
  4. Study completionDec 2015

Resources

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668811
Sponsor's protocol ID
WCI-2007-214
Acronym
IIT Sutent
Status last verified
Aug 2020
First submitted
25 Apr 2008
Last updated
5 Aug 2020
Data monitoring committee
Yes

Publications

  • Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C, Slamon D. A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother Pharmacol. 2008 Mar;61(3):515-24. doi: 10.1007/s00280-007-0498-4. Epub 2007 May 16.

    PubMed 17505827

  • Bikas A, Kundra P, Desale S, Mete M, O'Keefe K, Clark BG, Wray L, Gandhi R, Barett C, Jelinek JS, Wexler JA, Wartofsky L, Burman KD. Phase 2 clinical trial of sunitinib as adjunctive treatment in patients with advanced differentiated thyroid cancer. Eur J Endocrinol. 2016 Mar;174(3):373-80. doi: 10.1530/EJE-15-0930. Epub 2015 Dec 15.

    PubMed 26671977

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SU011248, Sutent in people with Papillary Thyroid Cancer and Follicular Thyroid Cancer, run by Medstar Health Research Institute at 1 site 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 22 inclusion and 15 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 18 Apr 2018). 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?

Progression Free Survival (time frame: 12 months after last patient completes treatment). 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 NCT00668811, which also lists 2 linked publications.

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 5 Aug 2020.

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