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

Anaplastic Thyroid Cancer Clinical Trial

Official title:

Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00095693
• Other study ID #: NCI-2012-01457
• Secondary ID: NCI-2012-01457OS
• Status: Terminated
• Phase: Phase 2
• First received: November 5, 2004
• Last updated: January 15, 2014
• Start date: October 2004
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2011
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Thyroid Cancer
• Carcinoma
• 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
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• sorafenib tosylate
Given PO

Other:
• laboratory biomarker analysis
Correlative studies
• pharmacological study
Correlative studies

Radiation:
• fludeoxyglucose F 18
Correlative studies

Procedure:
• positron emission tomography
Correlative studies
• dynamic contrast-enhanced magnetic resonance imaging
Correlative studies

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The 95% confidence intervals should be provided.	Up to 4 weeks	No
Secondary	Incidence of toxicity		Up to 4 weeks	Yes