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

This study has been completed.
Sponsor:
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00887107
First received: April 22, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 22, 2009
April 22, 2009
October 2007
Not Provided
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma
Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma

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

Background of the study:

Therapy with radioiodine (RaI) is the only curative therapy in non-medullary thyroid carcinoma. RaI uptake is frequently lost in this disease. Therapy with tyrosine kinase inhibitors may restore the susceptibility to RaI.

Objective of the study:

To investigate whether therapy with the tyrosine kinase inhibitor Sorafenib will increase the accumulation of radioiodine (RaI) and decrease tumor progression in patients with recurrences or metastases of non-medullary thyroid carcinoma with absent or insufficient accumulation of RaI.

Study design:

Prospective, open study with patients with recurrences or metastases of differentiated thyroid carcinoma who will undergo 6 months therapy with Sorafenib 800 mg/day. Patients in whom RaI uptake will be restored will be offered high dose (6000 MBq) RaI together with an additional 6 months treatment with Sorafenib. Patients in whom RaI is not be restored but in whom Sorafenib had a favorable effect on tumor growth will be offered continued treatment with Sorafenib.

Study population:

Thirty patients will be included with recurrences or metastases of differentiated thyroid carcinoma that are unresponsive to RaI therapy.

Intervention (if applicable):

After inclusion, patients will undergo 131I scintigraphy as well as a CT scan. Thereafter, therapy with Sorafenib 800 mg/day will be initiated, and continued during 6 months. After 6 months, 131I scintigraphy and CT scans will be repeated. Serum levels of thyroglobulin will be used as tumormarker.

Primary study parameters/outcome of the study:

The endpoint of the study is the 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: The appearance of one or more RaI accumulating lesions at RaI scintigraphy, planar images and/or SPECT (see below)
  2. Serum thyroglobulin levels:

    The absence of progression: no statistically significant positive slope at linear regression of the log-transformed serum Tg levels, measured at 0, 4, 8, 12, 16, 20, 24 and 28 weeks after start of Sorafenib:

    • Stable disease: The slope at linear regression of the log-transformed serum Tg levels, measured at 0, 4, 8, 12, 16, 20, 24 and 28 weeks after start of Sorafenib is not significantly different from 0 ln ug/L*time OR
    • Response: The slope at linear regression of the log-transformed serum Tg levels is negative (statistically significantly below 0 ln ug/L*time).
  3. CT Imaging:

The absence of progression according to RECIST criteria:

  • Stable disease—neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
  • Partial response—at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter;
  • Complete response: the disappearance of all target lesions
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroid Cancer
Drug: Sorafenib (nexavar)
6 months therapy with Sorafenib 800 mg/day
Other Name: nexavar
Experimental: sorafenib
30 patients with non-radioiodine avid differentiated thyroid carcinoma
Intervention: Drug: Sorafenib (nexavar)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Other active malignancies
  • Active kidney, liver or pancreatic disease or dysfunction
  • Unstable angina pectoris or recent (<3 months) myocardial infarction.
  • Coagulopathy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00887107
NL17727.058.07, P07.109
No
Johannes Smit, M.D., Ph.D., leiden University Medical Center
Leiden University Medical Center
Not Provided
Principal Investigator: Johannes W Smit, MD, PhD Leiden Universty Medical Center
Leiden University Medical Center
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP