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Anaplastic Thyroid CancerPhase 2NCT00095693

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

A Phase 2 study testing sorafenib tosylate, laboratory biomarker analysis and pharmacological study in people with Anaplastic Thyroid Cancer and Insular Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sorafenib tosylate, laboratory biomarker analysis and pharmacological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Oct 2004to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 51Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
sorafenib tosylate, laboratory biomarker analysis, pharmacological study, fludeoxyglucose F 18, positron emission tomography
Medical subject headings
Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG

    Correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Correlative studies

  • dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery

    Also called DCE-MRI

    Correlative studies

Study groups in NCT00095693
Study groupRoleWhat they receive
Treatment (sorafenib tosylate)ExperimentalPatients 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.
Receives: Drug: sorafenib tosylate; Other: laboratory biomarker analysis; Other: pharmacological study; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: dynamic contrast-enhanced magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    The 95% confidence intervals should be provided.

    Measured: Up to 4 weeks

Secondary outcomes (1)

  1. Incidence of toxicity

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionAug 2005
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095693
Sponsor's protocol ID
NCI-2012-01457
Other IDs
NCI-2012-01457, OSU-0441, CDR0000393968, NCI-6608, OSU-2004C0068, OSU 0441, 6608, N01CM62207
Status last verified
Jan 2014
First submitted
5 Nov 2004
Last updated
16 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate, laboratory biomarker analysis and pharmacological study in people with Anaplastic Thyroid Cancer and Insular Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 51 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.

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