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Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00095693
Recruitment Status : Terminated
First Posted : November 8, 2004
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anaplastic Thyroid Cancer Insular Thyroid Cancer Recurrent Thyroid Cancer Stage III Follicular Thyroid Cancer Stage III Papillary Thyroid Cancer Stage IV Follicular Thyroid Cancer Stage IV Papillary Thyroid Cancer Drug: sorafenib tosylate Other: laboratory biomarker analysis Other: pharmacological study Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine objective response rate in patients with locally advanced, metastatic, or locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006).

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients. II. Correlate thyroglobulin levels with tumor response in patients treated with this drug.

III. Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response in patients treated with this drug.

IV. Correlate tumor permeability and vascularity, as determined by dynamic contrast-enhanced MRI, with tumor response in patients treated with this drug.

V. Determine the pharmacodynamics of this drug in these patients. VI. Correlate the presence and type of B-raf, N-ras, or RET/PTC gene mutations with clinical response in patients treated with this drug.

VII. Correlate the degree of Ras-MAPK signaling inhibition and vascular endothelial growth factor expression with clinical response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (papillary thyroid cancer that is chemo-naïve vs all others).

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

Patients are followed within 2-4 weeks after completion of study treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
Study Start Date : October 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (sorafenib tosylate)
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 tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

Other: laboratory biomarker analysis
Correlative studies

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Radiation: fludeoxyglucose F 18
Correlative studies
Other Names:
  • 18FDG
  • FDG

Procedure: positron emission tomography
Correlative studies
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

Procedure: dynamic contrast-enhanced magnetic resonance imaging
Correlative studies
Other Name: DCE-MRI


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 4 weeks ]
    The 95% confidence intervals should be provided.


Secondary Outcome Measures :
  1. Incidence of toxicity [ Time Frame: Up to 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Archival tumor tissue block OR material collected before study entry available (stratum I)
  • Biopsy-accessible disease (stratum I)
  • Performance status - ECOG 0-1
  • At least 6 months
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • No bleeding diathesis
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • AST and ALT =< 1.5 times ULN
  • Creatinine =< 1.5 times ULN
  • No uncontrolled hypertension
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to undergo 2 tumor biopsies during study participation (stratum I)
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No other concurrent malignancy except nonmetastatic nonmelanoma skin cancer or carcinoma in situ of the cervix

  • No prior systemic chemotherapy for thyroid cancer (stratum I)

    • Prior systemic chemotherapy used to treat a second primary cancer with curative intent allowed provided the primary cancer was treated more than 5 years before study entry
  • No more than 3 prior systemic chemotherapy regimens for thyroid cancer (stratum II)
  • More than 6 weeks since prior systemic chemotherapy (stratum II)
  • No prior external beam radiotherapy to the sole site of measurable disease (except for patients with anaplastic thyroid cancer)
  • More than 6 weeks since prior external beam radiotherapy
  • More than 24 weeks since prior iodine I 131
  • Recovered from all prior therapy
  • No prior sorafenib
  • More than 6 weeks since prior investigational tumor-specific therapy
  • Concurrent oral or IV bisphosphonates for bony metastases allowed at the discretion of the investigator
  • No other concurrent tumor-specific or investigational therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients

  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) for venous or arterial access devices allowed provided PT, INR, or PTT are normal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095693


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Manisha Shah Ohio State University
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095693    
Other Study ID Numbers: NCI-2012-01457
NCI-2012-01457 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU-0441
CDR0000393968
NCI-6608
OSU-2004C0068
OSU 0441 ( Other Identifier: Ohio State University Medical Center )
6608 ( Other Identifier: CTEP )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
U01CA076576 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2004    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Carcinoma, Anaplastic
Adenocarcinoma, Follicular
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Adenocarcinoma, Papillary
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sorafenib
Fluorodeoxyglucose F18
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals