Sutent Adjunctive Treatment of Differentiated Thyroid Cancer - Full Text View

Sponsors and Collaborators:	Washington Hospital Center Pfizer
Information provided by:	Washington Hospital Center
ClinicalTrials.gov Identifier:	NCT00668811

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 followed by 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 II

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Sunitinib Sunitinib malate Iodine Cadexomer iodine Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

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:	43
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed stage 3 or stage 4 differentiated thyroid cancer (i.e., papillary or follicular thyroid cancer)or metastatic stage 2 thyroid cancer
Distant metastases documented by any combination of radiologic studies or whole body radioiodine scanning.
Thyroglobulin levels considered inappropriate elevated:
- >60 with thyroid gland
- >1 without thyroid gland
Life expectancy ≥ 3 months
adequacy of organ function required prior to study entry as per protocol
Agreement to use contraceptives for women with childbearing 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

Exclusion Criteria:

Prior systemic chemotherapy within 3 months
Prior treatment on a SU011248 clinical trial or Current treatment on another clinical trial
Prior external beam radiation therapy within 3 months, unless radiotherapy did not involve target lesion.
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
Serious uncontrolled concomitant disease that the Investigator feels might compromise study participation.
Lack of physical integrity of the upper gastrointestinal tract or
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
Known human immunodeficiency virus infection.
Current treatment with therapeutic doses of Coumadin (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.
Unwillingness to participate or inability to comply with the protocol for the duration of the study.

Contacts and Locations

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

Contacts

Contact: Grant A Rush, BS

202-877-8839

wci.clinicaltrials@medstar.net

Locations

United States, District of Columbia
Washington Cancer Institute at the Washington Hospital Center	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Grant Rush
Principal Investigator: Kenneth D Burman, MD
Sub-Investigator: Yasser Ousman, MD
Sub-Investigator: Jason Wexler, MD

Sponsors and Collaborators

Washington Hospital Center

Pfizer

Investigators

Principal Investigator:

Kenneth D Burman, MD

Washington Hospital Center

More Information

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. Epub 2007 May 16.

Responsible Party:	Washington Hospital Center ( Kennth D. Burman, MD, Principal Investigator, Sponsor )
Study ID Numbers:	WCI-2007-214
Study First Received:	April 25, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00668811
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Adenocarcinoma, Follicular
Thyroid Neoplasms
Endocrine System Diseases
Carcinoma
Thyroid cancer, papillary
Sunitinib
Head and Neck Neoplasms

Iodine
Endocrinopathy
Adenocarcinoma
Thyroid Diseases
Thyroid cancer, follicular
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009