Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington Hospital Center
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Washington Hospital Center
ClinicalTrials.gov Identifier:
NCT00668811
First received: April 25, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Papillary Thyroid Cancer
Follicular Thyroid Cancer
Differentiated Thyroid Cancer
Drug: SU011248, Sutent
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Washington Hospital Center:

Primary Outcome Measures:
  • The primary objective is to assess clinical benefit rate, defined as complete response, partial response, or stable disease per RECIST criteria. [ Time Frame: 12 months after last patient completes treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective will be to assess the safety of Sutent in this patient population. [ Time Frame: quarterly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: April 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm - Sutent
Sutent 37.5 mg/day will be given orally.
Drug: SU011248, Sutent
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.
Other Name: Sunitinib

Detailed Description:

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 physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668811

Contacts
Contact: Lynette Wray 202-877-2749 lynette.wray@medstar.net

Locations
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Lynette Wray    202-877-2749    lynette.wray@medstar.net   
Principal Investigator: Kenneth D Burman, MD         
Sub-Investigator: Jason Wexler, MD         
Sub-Investigator: Priya Kundra, MD         
Sponsors and Collaborators
Washington Hospital Center
Pfizer
Investigators
Principal Investigator: Kenneth D Burman, MD Washington Hospital Center
  More Information

Publications:
Responsible Party: Washington Hospital Center
ClinicalTrials.gov Identifier: NCT00668811     History of Changes
Other Study ID Numbers: WCI-2007-214
Study First Received: April 25, 2008
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Washington Hospital Center:
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

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Adenocarcinoma, Follicular
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014