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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00095693
First received: November 5, 2004
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    The 95% confidence intervals should be provided.


Secondary Outcome Measures:
  • Incidence of toxicity [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: October 2004
Study Completion Date: December 2011
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Investigators
Principal Investigator: Manisha Shah Ohio State University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095693     History of Changes
Other Study ID Numbers: NCI-2012-01457, NCI-2012-01457, OSU-0441, CDR0000393968, NCI-6608, OSU-2004C0068, OSU 0441, 6608, N01CM62207, P30CA016058, N01CM62206, U01CA076576
Study First Received: November 5, 2004
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Adenocarcinoma, Follicular
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fluorodeoxyglucose F18
Sorafenib
Niacinamide
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014