Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

NCT00668811 | Completed Phase 2 Results DMC

• 1 other identifier: WCI-2007-214
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Papillary Thyroid Cancer; Follicular Thyroid Cancer; Differentiated Thyroid Cancer

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

Outcome Measures

Primary Outcomes (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).

  12 months after last patient completes treatment

Secondary Outcomes (1)

• Overall Survival

  12 months after last patient completes treatment

Study Arms (1)

Treatment Arm - Sutent

EXPERIMENTAL

Sutent 37.5 mg/day will be given orally.

Drug: SU011248, Sutent

Interventions

SU011248, Sutent DRUG

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.

Also known as: Sunitinib

Treatment Arm - Sutent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• a. If a patient has distant metastases, it must be documented by any combination of radiographic studies or whole body radioiodine scanning.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

• 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.

  PMID: 17505827 BACKGROUND

• 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.

  PMID: 26671977 RESULT

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr Kenneth D. Burman
• Organization: MedStar Washington Hospital Center

kenneth.d.burman@medstar.net

202-877-8109

Study Officials

• Kenneth D Burman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 5, 2020
• Results First Posted: April 18, 2018

Record last verified: 2020-08

Locations

US (1)