NCT00095693

Brief Summary

Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

November 5, 2004

Last Update Submit

January 15, 2014

Conditions

Anaplastic Thyroid CancerInsular Thyroid CancerRecurrent Thyroid CancerStage III Follicular Thyroid CancerStage III Papillary Thyroid CancerStage IV Follicular Thyroid CancerStage IV Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    The 95% confidence intervals should be provided.

    Up to 4 weeks

Secondary Outcomes (1)

  • Incidence of toxicity

    Up to 4 weeks

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.

Drug: sorafenib tosylateOther: laboratory biomarker analysisOther: pharmacological studyRadiation: fludeoxyglucose F 18Procedure: positron emission tomographyProcedure: dynamic contrast-enhanced magnetic resonance imaging

Interventions

sorafenib tosylateDRUG

Given PO

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (sorafenib tosylate)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (sorafenib tosylate)
fludeoxyglucose F 18RADIATION

Correlative studies

Also known as: 18FDG, FDG
Treatment (sorafenib tosylate)
positron emission tomographyPROCEDURE

Correlative studies

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Treatment (sorafenib tosylate)
dynamic contrast-enhanced magnetic resonance imagingPROCEDURE

Correlative studies

Also known as: DCE-MRI
Treatment (sorafenib tosylate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of 1 of the following:
  • Papillary thyroid cancer (stratum I)
  • Papillary, follicular, Hurthle cell, insular, or anaplastic thyroid cancer (stratum II)
  • Mixed histology, poorly differentiated, or tall-cell variants allowed
  • Metastatic, locally advanced, or locally recurrent disease
  • At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
  • The following are considered non-measurable disease:
  • Tumors in a previously irradiated area
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Thyroid Carcinoma, AnaplasticThyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, Papillary

Interventions

SorafenibFluorodeoxyglucose F18Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaAdenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Manisha Shah

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2004

First Posted

November 8, 2004

Study Start

October 1, 2004

Primary Completion

August 1, 2005

Study Completion

December 1, 2011

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

US(1)