District of Columbia
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 one year after completing standard therapy. During this
time, study participants will be followed closely by their doctor.
This is a two-stage, phase II with historical controls, 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 in comparison to historical controls. 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
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
To be eligible for inclusion, patients must fulfill each of the following criteria:
1. 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.
2. Age >18 years.
3. Histologically confirmed stage 2 (younger than 45 years of age), 3 or stage 4
differentiated thyroid cancer (i.e., papillary or follicular thyroid cancer).
a. If a patient has distant metastases, it must be documented by any combination of
radiographic studies or whole body radioiodine scanning.
4. Previously treated with at least one course of radioactive iodine (I-131) therapy.
5. At least one measurable site of disease as defined by the Tumor Assessment Criteria
in Appendix 3.
6. Serum thyroglobulin levels inappropriately elevated:
> 60 ng/mL with thyroid gland > 1 ng/mL without thyroid gland
7. ECOG performance status 0-2.
8. Life expectancy ≥ 3 months.
9. Normal organ function. The definitions of minimum adequacy for organ function
required prior to study entry are as follows:
1. 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
2. Total serum bilirubin less than or equal to 1.5 x ULN.
3. Serum albumin greater than or equal to 3.0 g/dL.
4. Absolute neutrophil count (ANC) greater than or equal to 1500/uL.
5. Platelets greater than or equal to 100,000/uL.
6. Hemoglobin greater than or equal to 9.0 g/dL
7. Serum creatinine less than or equal to 1.5 x ULN.
10. Agreement to use contraceptives for women with child bearing potential. Unless
surgically sterile, men must agree to use effective contraception during period of
11. 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
Patients who fulfill any of the following criteria will be excluded:
1. Prior systemic chemotherapy or targeted therapy within 3 months prior to enrollment.
2. Prior treatment on a Sutent clinical trial or current treatment on another clinical
3. Prior external beam radiation therapy to the target lesion(s).
4. Life expectancy < 3 months.
5. History of any other carcinomas within the last 5 years, except cured basal cell
carcinoma of the skin and cured in-situ cervical cancer.
6. Serious uncontrolled concomitant disease that the Investigator feels might compromise
7. Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome, or the inability to take oral medication.
8. 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.
9. Uncontrollable hypertension.
10. Known human immunodeficiency virus infection.
11. 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).
12. 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.
13. Inability to swallow whole tablets.
14. Unwillingness to participate or inability to comply with the protocol for the
duration of the study.