- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00095693
Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
Patients achieving CR receive 8 additional weeks of therapy beyond CR.
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Correlative studies
Correlative studies
Other Names:
Correlative studies
Other Names:
Correlative studies
Other Names:
Given PO
Other Names:
Correlative studies
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: Up to 4 weeks
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The 95% confidence intervals should be provided.
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Up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of toxicity
Time Frame: Up to 4 weeks
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Up to 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manisha Shah, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Adenocarcinoma, Papillary
- Thyroid Diseases
- Thyroid Neoplasms
- Thyroid Cancer, Papillary
- Adenocarcinoma, Follicular
- Thyroid Carcinoma, Anaplastic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Radiopharmaceuticals
- Protein Kinase Inhibitors
- Fluorodeoxyglucose F18
- Sorafenib
Other Study ID Numbers
- NCI-2012-01457 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA016058 (U.S. NIH Grant/Contract)
- N01CM62207 (U.S. NIH Grant/Contract)
- N01CM62206 (U.S. NIH Grant/Contract)
- U01CA076576 (U.S. NIH Grant/Contract)
- OSU-0441
- CDR0000393968
- NCI-6608
- OSU-2004C0068
- OSU 0441 (Other Identifier: Ohio State University Medical Center)
- 6608 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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