Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

NCT00126568 | Terminated Phase 2 Results

• 5 other identifiers: NCI-2009-00118CASE 5304CDR00004377897037U01CA062502
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anaplastic Thyroid Cancer; Recurrent Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Response to Treatment Measured by RECIST Criteria

  Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, x-ray) or as \>10 mm with spiral CT scan.

  at 6 months after treatment

Secondary Outcomes (3)

• Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.

  27 months

• Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.

  27 months

• Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006

  27 months

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

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

Drug: sorafenib tosylate

Interventions

sorafenib tosylate DRUG

Given orally

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

Treatment (sorafenib tosylate)

Eligibility Criteria

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

Criteria: * Progressive disease after prior cytotoxic chemotherapy (i.e., chemotherapy alone or combined with radiotherapy) * No symptomatic bulky disease that would impair the airway or impede swallowing (for patients with ECOG performance status 2) * No known brain metastases * 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 * 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 * Performance status: * ECOG 0-2 OR Karnofsky 50-100% * Life expectancy more than 8 weeks * Absolute neutrophil count \>= 1,250/mm3 * Platelet count \>= 100,000/mm3 * No evidence of bleeding diathesis * Bilirubin =\< 1.5 times upper limit of normal (ULN) * PTT =\< 1.5 times ULN * Creatinine =\< 1.5 times ULN * No myocardial infarction within 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 uncontrolled hypertension (i.e., systolic blood pressure (BP) \> 150 mm Hg OR diastolic BP \> 100 mm Hg) * 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 * 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 * At least 7 days since prior radiotherapy and recovered * 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 * Histologically confirmed anaplastic\* thyroid cancer * Not amenable to definitive curative surgery or radiotherapy \[Note: \*Papillary, follicular, or other histologies that are mixed or identified in a diagnostic tissue sample are allowed provided a high-grade undifferentiated anaplastic component is present \] * No cardiac arrhythmia * AST and ALT =\< 3.5 times ULN * INR \< 2.0

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Savvides P, Nagaiah G, Lavertu P, Fu P, Wright JJ, Chapman R, Wasman J, Dowlati A, Remick SC. Phase II trial of sorafenib in patients with advanced anaplastic carcinoma of the thyroid. Thyroid. 2013 May;23(5):600-4. doi: 10.1089/thy.2012.0103. Epub 2013 Apr 18.

  PMID: 23113752 DERIVED

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic; Thyroid Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

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

Limitations and Caveats

The study met the pre-specified criteria for enrollment of all planned 32 patients. However due to poor accrual the study was halted.

Results Point of Contact

• Title: Dr. Panayiotis Savvides
• Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Panayiotis.Savvides@uhhospitals.org

216-844-5946

Study Officials

• Panayiotis Savvides

  Case Western Reserve University

  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: August 2, 2005
• First Posted: August 4, 2005
• Study Start: June 1, 2005
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 19, 2018
• Results First Posted: August 10, 2012

Record last verified: 2017-12

Locations

US (1)