Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Condition: Papillary Thyroid Cancer; Follicular Thyroid Cancer; Differentiated Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid Diseases
Intervention: SU011248, Sutent
Intervention description: 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.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        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:

          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 malignancy.

               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
             therapy.

         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 informed
             consent.

        Exclusion Criteria:

        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
             trial.

          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
             study participation.

          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.