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Sorafenib (BAY 43-9006) in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
This study has been completed.
First Received: November 5, 2004   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095693
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of sorafenib in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer
Drug Information available for: Sorafenib Sorafenib tosylate Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Pharmacodynamics [ Designated as safety issue: No ]
  • Correlation of thyroglobulin levels with tumor response [ Designated as safety issue: No ]
  • Correlation of fludeoxyglucose F 18 positron emission tomography results with tumor response [ Designated as safety issue: No ]
  • Correlation of tumor permeability and vascularity as determined by dynamic contrast-enhanced MRI, with tumor response [ Designated as safety issue: No ]
  • Correlation of the presence and type of B-raf, N-ras, or RET/PTC gene mutations with clinical response [ Designated as safety issue: No ]
  • Correlation of the degree of Ras-MAPK signaling inhibition and vascular endothelial growth factor expression with clinical response [ Designated as safety issue: No ]

Study Start Date: November 2004
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • Determine the toxicity of this drug in these patients.
  • Correlate thyroglobulin levels with tumor response in patients treated with this drug.
  • Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response in patients treated with this drug.
  • Correlate tumor permeability and vascularity, as determined by dynamic contrast-enhanced MRI, with tumor response in patients treated with this drug.
  • Determine the pharmacodynamics of this drug in these patients.
  • Correlate the presence and type of B-raf, N-ras, or RET/PTC gene mutations with clinical response in patients treated with this drug.
  • 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 chemonaïve vs all others).

Patients receive oral sorafenib (BAY 43-9006) 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.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 7 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No uncontrolled hypertension

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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)

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • 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

Surgery

  • Not specified

Other

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095693

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000393968, OSU-0441, OSU-2004C0068, NCI-6608
Study First Received: November 5, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00095693     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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 placed in the following topic categories:
Adenocarcinoma, Follicular
Thyroid Neoplasms
Thyroid Cancer, Papillary
Endocrine System Diseases
Protein Kinase Inhibitors
Recurrence
Carcinoma
Thyroid Cancer, Follicular
Head and Neck Neoplasms
Thyroid Cancer, Anaplastic
Endocrinopathy
Sorafenib
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Thyroid Neoplasms
Antineoplastic Agents
Endocrine System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Sorafenib
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009