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Trial record 34 of 120 for:    medullary carcinoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00390325
Recruitment Status : Active, not recruiting
First Posted : October 19, 2006
Results First Posted : December 21, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 18, 2006
First Posted Date  ICMJE October 19, 2006
Results First Submitted Date  ICMJE May 8, 2018
Results First Posted Date  ICMJE December 21, 2018
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE October 5, 2006
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00390325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Number of Patients With Decreased Calcitonin Levels [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Identifying the number of patients with decreased calcitonin levels
  • Patient With Decreased Carcinoembryonic Antigen (CEA) Levels [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels
  • Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep) [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Median decrease in exchange rate Kep in index lesions
  • Degree of Ras-MAPK Signaling Inhibition in the Tumor [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Identify the number of patients with degree of Ras-MAPK signaling inhibition
  • Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with clinical response.
  • Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET) [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Identify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET).
  • Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Toxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
  • Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor [ Time Frame: Baseline ]
    Percent of patients with RET mutations
  • Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity [ Time Frame: Baseline ]
    Changes will be correlated with toxicity and clinical response to therapy.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer
Official Title  ICMJE Phase II Study of Sorafenib (BAY 43-9006) in Patients With Metastatic Medullary Thyroid Carcinoma
Brief Summary This phase II trial studies how well sorafenib tosylate works in treating patients with medullary thyroid cancer that has spread to other parts of the body (metastatic), spread to the tissue surrounding the thyroid (locally advanced), or has returned after a period of improvement (recurrent). Sorafenib tosylate 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.
Detailed Description

PRIMARY OBJECTIVES:

I. To assess objective response rate of sorafenib tosylate (sorafenib [BAY 43-9006]) in metastatic medullary thyroid carcinoma in setting of inherited tumor syndromes, such as multiple endocrine neoplasia (MEN) 2A, MEN 2B, or familial medullary thyroid carcinoma (FMTC).

II. To assess objective response rate of sorafenib (BAY 43-9006) in sporadic metastatic medullary thyroid carcinoma.

SECONDARY OBJECTIVES:

I. To assess toxicity of sorafenib (BAY 43-9006) in patients with metastatic medullary thyroid carcinoma.

II. Measure serum tumor markers calcitonin and carcinoembryonic antigen (CEA) pre-, during, and post-treatment to correlate with disease response.

III. Correlate nuclear medicine functional imaging (fludeoxyglucose F 18 [F-18 fluorodeoxyglucose] positron emission tomography [PET] scan) data obtained at pre-, during, and post-treatment with tumor response.

IV. Correlate dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) data obtained at pre-, during, and post-treatment with changes in tumor permeability and vascularity with tumor response.

V. Perform pharmacogenomic studies on procured peripheral blood mononuclear cells (PBMCs) if clinical responses are observed.

VI. To correlate between the degree of retrovirus-associated deoxyribonucleic acid (DNA) sequences (Ras)-mitogen-activated protein kinase (MAPK) signaling inhibition with vascular endothelial growth factor (VEGF) expression in the tumor and clinical response.

VII. To correlate between the presence and type of ret proto-oncogene (RET) gene defects in tumor and clinical response.

OUTLINE:

Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-56. Cycles repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hereditary Thyroid Gland Medullary Carcinoma
  • Multiple Endocrine Neoplasia Type 2A
  • Multiple Endocrine Neoplasia Type 2B
  • Recurrent Thyroid Gland Medullary Carcinoma
  • Stage III Thyroid Gland Medullary Carcinoma AJCC v7
  • Stage IV Thyroid Gland Medullary Carcinoma AJCC v7
  • Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7
  • Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7
  • Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7
Intervention  ICMJE
  • Drug: Sorafenib
    Given PO
    Other Names:
    • BA4 43 9006
    • BAY 43-9006
    • Bay-439006
  • Drug: Sorafenib Tosylate
    Given PO
    Other Names:
    • BAY 43-9006 Tosylate
    • BAY 54-9085
    • Nexavar
    • sorafenib
Study Arms  ICMJE Experimental: Treatment (sorafenib tosylate)
Patients receive sorafenib tosylate PO BID on days 1-56. Cycles repeats every 8 weeks in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: Sorafenib
  • Drug: Sorafenib Tosylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 20, 2018)
21
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ELIGIBILITY CRITERIA SPECIFIC FOR ARM A
  • Histologically confirmed medullary thyroid carcinoma under the clinical setting of inherited tumor syndromes, such as multiple endocrine neoplasia (MEN) 2A, MEN 2B, or familial medullary thyroid carcinoma (FMTC)
  • ELIGIBILITY CRITERIA SPECIFIC FOR ARM B
  • Histologically confirmed medullary thyroid carcinoma under the clinical setting of sporadic medullary thyroid carcinoma (MTC)
  • ELIGIBILITY CRITERIA COMMON FOR ARMS A AND B
  • Patients must have measurable disease
  • Metastatic and/or locally advanced or locally recurrent disease
  • Oral or intravenous (IV) bisphosphonates therapy will be allowed for patients with bony metastasis at the investigator's discretion; bisphosphonate usage should be recorded if used since these agents may have anti-farnesyl transferase activity and may have some therapeutic effect in combination with sorafenib
  • Life expectancy must be >= six months
  • Patients must have an Eastern Cooperative Oncology Group performance status 0-2
  • Leukocytes >= 2,000/uL (10 days prior to patient enrollment)
  • Absolute neutrophil count >= 1,000/uL (10 days prior to patient enrollment)
  • Platelets >= 100,000/uL (10 days prior to patient enrollment)
  • Total bilirubin =< within 2 x upper limit of normal (10 days prior to patient enrollment)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< within 3 x upper limit of normal (10 days prior to patient enrollment)
  • Serum creatinine within normal institutional limits OR creatinine clearance > 30 mL/min (by Cockcroft-Gault formula) (10 days prior to patient enrollment)
  • The effects of sorafenib (BAY 43-9006) on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because kinase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 30 days after completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately (10 days prior to patient enrollment)
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • EXCLUSION CRITERIA FOR ARM A AND B
  • Patients who have had systemic anti-tumor therapy (such as chemotherapy, biologic modifiers or antiangiogenic therapy) within 4 weeks (6 weeks if nitrosourea or mitomycin chemotherapy) prior to study entry
  • Patients who have had external beam radiation therapy within 1 week or if the adverse events associated with radiation are not resolved to grade 1 or less prior to study entry
  • Prior therapy with sorafenib (BAY 43-9006), ZD 6474 or AMG-706
  • Patients currently receiving any other tumor-specific therapy for thyroid cancer or investigational therapy; patients receiving adjuvant hormonal therapy for a second primary (such as breast cancer or prostate cancer) are allowed to participate as far as there are no known drug interactions
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib (BAY 43-9006)
  • Patients unable to swallow sorafenib tablets (e.g. any condition that impairs patient's ability to swallow pills)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with any evidence of a bleeding diathesis
  • Patients actively receiving anticoagulation with therapeutic intent; prophylactic anticoagulation (i.e. low dose warfarin) or venous or arterial access devices is allowed provided that the prothrombin time (PT), international normalized ratio (INR) or partial thromboplastin time (PTT) are normal
  • Pregnant women or women who are breast-feeding are excluded from this study because sorafenib (BAY 43-9006) is an investigational agent and teratogenicity has not been evaluated yet; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sorafenib (BAY 43-9006), breastfeeding should be discontinued if the mother is treated with sorafenib (BAY 43-9006)
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with sorafenib (BAY 43-9006); patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
  • Patients taking the cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin or St. John's wort due to potential drug interactions with sorafenib
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00390325
Other Study ID Numbers  ICMJE NCI-2009-00196
NCI-2009-00196 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006C0050
NCI-7609
CDR0000507441
OSU 06054 / IRB 2006C0050
7609 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
7609 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bhavana Konda Ohio State University Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP