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

Phase 2
18 Years
Not Enrolling
Anaplastic Thyroid Cancer, 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

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Trial Information

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


I. Determine objective response rate in patients with locally advanced, metastatic, or
locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006).


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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate

Outcome Description:

The 95% confidence intervals should be provided.

Outcome Time Frame:

Up to 4 weeks

Safety Issue:


Principal Investigator

Manisha Shah

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Anaplastic Thyroid Cancer
  • 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 Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular



Ohio State University Medical Center Columbus, Ohio  43210