Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma

NCT00887107 | Completed Phase 2

• 2 other identifiers: NL17727.058.07P07.109
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether therapy with Sorafenib reinduces radioiodine uptake in thyroid carcinoma.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a favorable response to Sorafenib defined as ONE OR MORE of the following criteria: 1. Reinduction of RaI uptake by RaI scintigraphy. 2. Serum thyroglobulin levels. 3. RECIST criteria

  6 months

Study Arms (1)

sorafenib

EXPERIMENTAL

30 patients with non-radioiodine avid differentiated thyroid carcinoma

Drug: Sorafenib (nexavar)

Interventions

Sorafenib (nexavar) DRUG

6 months therapy with Sorafenib 800 mg/day

Also known as: nexavar

sorafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-medullary thyroid carcinoma
• The patients must have undergone total thyroidectomy
• Presence of metastases or inoperable recurrent disease, as proven by elevated serum thyroglobulin levels (Tg) in combination with radiological evidence for tumor
• No or insufficient RaI uptake in tumor as proven by RaI scintigraphy, performed after prior RaI therapy

You may not qualify if:

• Pregnancy
• Other active malignancies
• Active kidney, liver or pancreatic disease or dysfunction
• Unstable angina pectoris or recent (\<3 months) myocardial infarction.
• Coagulopathy

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (2)

• Abdulrahman RM, Verloop H, Hoftijzer H, Verburg E, Hovens GC, Corssmit EP, Reiners C, Gelderblom H, Pereira AM, Kapiteijn E, Romijn JA, Visser TJ, Smit JW. Sorafenib-induced hypothyroidism is associated with increased type 3 deiodination. J Clin Endocrinol Metab. 2010 Aug;95(8):3758-62. doi: 10.1210/jc.2009-2507. Epub 2010 May 19.

  PMID: 20484486 DERIVED

• Hoftijzer H, Heemstra KA, Morreau H, Stokkel MP, Corssmit EP, Gelderblom H, Weijers K, Pereira AM, Huijberts M, Kapiteijn E, Romijn JA, Smit JW. Beneficial effects of sorafenib on tumor progression, but not on radioiodine uptake, in patients with differentiated thyroid carcinoma. Eur J Endocrinol. 2009 Dec;161(6):923-31. doi: 10.1530/EJE-09-0702. Epub 2009 Sep 22.

  PMID: 19773371 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Johannes W Smit, MD, PhD

  Leiden Universty Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: October 1, 2007
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

NL (1)