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About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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)
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:
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)
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
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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