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

NCT00390325 | Completed Phase 2 Results DMC

• 9 other identifiers: NCI-2009-001962006C0050NCI-7609CDR0000507441OSU 06054 / IRB 2006C00507609N01CM00070N01CM62207P30CA016058
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Hereditary Thyroid Gland Medullary Carcinoma; Locally Advanced Thyroid Gland Medullary Carcinoma; Multiple Endocrine Neoplasia Type 2A; Multiple Endocrine Neoplasia Type 2B; Recurrent Thyroid Gland Medullary Carcinoma; Sporadic 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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Up to 4 weeks after last dose of sorafenib tosylate

Secondary Outcomes (9)

• Number of Patients With Decreased Calcitonin Levels

  Up to 4 weeks after last dose of sorafenib tosylate

• Patient With Decreased Carcinoembryonic Antigen (CEA) Levels

  Up to 4 weeks after last dose of sorafenib tosylate

• Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep)

  Up to 4 weeks after last dose of sorafenib tosylate

• Degree of Ras-MAPK Signaling Inhibition in the Tumor

  Up to 4 weeks after last dose of sorafenib tosylate

• Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor

  Up to 4 weeks after last dose of sorafenib tosylate

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive sorafenib tosylate PO BID in the absence of disease progression or unacceptable toxicity.

Drug: Sorafenib Tosylate

Interventions

Sorafenib Tosylate DRUG

Given PO

Also known as: BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib

Treatment (sorafenib tosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Familial medullary thyroid carcinoma; Multiple Endocrine Neoplasia Type 2a; Multiple Endocrine Neoplasia Type 2b; Carcinoma, Medullary

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Manisha Shah, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Manisha.Shah@osumc.edu

614-293-8629

Study Officials

• Bhavana Konda

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: November 3, 2006
• Primary Completion: January 30, 2017
• Study Completion: December 22, 2022
• Last Updated: February 6, 2024
• Results First Posted: December 21, 2018

Record last verified: 2024-01

Locations

US (3)