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Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
This study is ongoing, but not recruiting participants.

First Received on August 2, 2005.   Last Updated on October 4, 2011   History of Changes
Sponsor: Case Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00126568
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer.


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

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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Objective disease response [ Time Frame: at 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To further characterize the safety profile of BAY 43-9006 when given to patients with advanced anaplastic carcinoma of the thyroid. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2005
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sorafenib tosylate
    Administered on a fixed daily oral dosing schedule of 400 mg PO BID. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
    Other Name: BAY 43-9006
Detailed Description:

OBJECTIVES:

  • Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib.
  • Determine the survival of patients treated with this drug.
  • Determine the safety profile of this drug in these patients.
  • Determine the pharmacokinetic predictors of response to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed anaplastic* thyroid cancer

    • Not amenable to definitive curative surgery or radiotherapy NOTE: *Papillary, follicular, or other histologies that are mixed or identified in a diagnostic tissue sample are allowed provided a high-grade undifferentiated anaplastic component is present
  • Progressive disease after prior cytotoxic chemotherapy (i.e., chemotherapy alone or combined with radiotherapy)
  • Measurable or evaluable disease

    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Measurable disease not in a previously irradiated field
  • No symptomatic bulky disease that would impair the airway or impede swallowing (for patients with ECOG performance status 2)
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100%

Life expectancy

  • More than 8 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,250/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No evidence of bleeding diathesis

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3.5 times ULN
  • PTT ≤ 1.5 times ULN
  • INR < 2.0

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No myocardial infarction within the past 6 months
  • Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible provided disease has been stable for the past 6 months
  • No New York Heart Association class III or IV cardiac disease
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension (i.e., systolic blood pressure (BP) > 150 mm Hg OR diastolic BP > 100 mm Hg)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow oral medication
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No more than 2 prior systemic cytotoxic chemotherapy regimens

    • Combined modality systemic cytoxic chemotherapy is considered 1 prior cytotoxic regimen
  • At least 7 days since prior chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 7 days since prior radiotherapy and recovered

Surgery

  • Recovered from prior surgery

Other

  • No prior sorafenib or other inhibitors of MAP kinase signaling intermediates
  • No prior cancer treatment that would preclude study participation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No concurrent Hypericum perforatum (St. John's wort) or rifampin
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided requirements for INR and PTT are met
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126568

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
UH-Chagrin Highlands
Orange Village, Ohio, United States, 44122
UH-Westlake
Westlake, Ohio, United States, 44145
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Panayiotis Savvides, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00126568     History of Changes
Other Study ID Numbers: CASE5304, U01CA062502, P30CA043703, CASE-5304, NCI-7037
Study First Received: August 2, 2005
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
anaplastic thyroid cancer
recurrent thyroid cancer

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

ClinicalTrials.gov processed this record on February 09, 2012