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

NCT ID: NCT00095693

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sorafenib tosylate

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

fludeoxyglucose F 18

Intervention Type: RADIATION

Correlative studies

positron emission tomography

Intervention Type: PROCEDURE

Correlative studies

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

Correlative studies

Interventions

sorafenib tosylate

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

fludeoxyglucose F 18

Correlative studies

Intervention Type: RADIATION

positron emission tomography

Correlative studies

Intervention Type: PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Correlative studies

Intervention Type: PROCEDURE

Other Intervention Names

BAY 43-9006; BAY 43-9006 Tosylate Salt; BAY 54-9085; Nexavar; SFN; pharmacological studies; 18FDG; FDG; FDG-PET; PET; PET scan; tomography, emission computed; DCE-MRI

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manisha Shah

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

NCI-2012-01457

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-0441

Identifier Type: -

Identifier Source: secondary_id

CDR0000393968

Identifier Type: -

Identifier Source: secondary_id

NCI-6608

Identifier Type: -

Identifier Source: secondary_id

OSU-2004C0068

Identifier Type: -

Identifier Source: secondary_id

OSU 0441

Identifier Type: OTHER

Identifier Source: secondary_id

6608

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA016058

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62206

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA076576

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01457

Identifier Type: -

Identifier Source: org_study_id