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

Primary Purpose

Anaplastic Thyroid Cancer, Insular Thyroid Cancer, Recurrent Thyroid Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
laboratory biomarker analysis
pharmacological study
fludeoxyglucose F 18
positron emission tomography
dynamic contrast-enhanced magnetic resonance imaging
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate
The 95% confidence intervals should be provided.

Secondary Outcome Measures

Incidence of toxicity

Full Information

First Posted
November 5, 2004
Last Updated
January 15, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00095693
Brief Title
Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
Official Title
Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
18FDG, FDG
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Other Intervention Name(s)
DCE-MRI
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Objective response rate
Description
The 95% confidence intervals should be provided.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Incidence of toxicity
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Shah
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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