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Thyroid CancerPhase 2NCT01025453

Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer

A Phase 2 study testing Temsirolimus and Sorafenib in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Temsirolimus and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
5 sitesUnited States
Study dates
1 Dec 2009to 16 Jan 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patients must have histopathologically confirmed at MSKCC thyroid carcinoma of follicular cell origin (D-TC-FCO), which includes papillary, follicular, Hürthle cell histology, or anaplastic along with their respective variants.
  • Available pathology for RAF mutational testing (e.g., paraffin block or 5-10 unstained slides). It is not required that mutational testing be completed before starting the clinical study.
  • Patients must have surgically inoperable and/or recurrent/metastatic disease.
  • Patients must have a PET scan prior to the protocol start date and have at least one FDGavid lesion that has not been removed surgically or radiated (unless it has progressed by RECIST criteria after the completion of radiation therapy and is still FDG-avid). FDGavidity will be defined as any focus of increased FDG uptake greater than normal activity with SUV maximum levels greater than or equal to 3. PET scan can have been done at any time prior to the start of therapy, although it is recommended that it be done within 3 months prior to the start of therapy.
  • Patients must have measurable disease by RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan; performed ≤ 4 weeks of protocol start date.
  • Patients must have progressive disease defined by at least one of the following occurring during or after previous treatment (including RAI treatment):
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  • The presence of new or progressive lesions on CT/MRI.
  • New lesions on bone scan or PET scan.
  • Rising thyroglobulin level (documented by a minimum of three consecutive rises, with an interval of > 1 week between each determination).
  • Prior RAI therapy is allowed if > 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim. A diagnostic study using <10 mCi of RAI is not considered RAI therapy.
  • Patients may have received prior external beam radiation therapy to index lesions ≥ 4 weeks prior to initiation of therapy on this protocol if there has been documented progression by RECIST criteria. Prior external beam radiation therapy to the non-index lesions is allowed if ≥ 4 weeks prior to initiation of therapy on this protocol.
  • ECOG performance status ≤ 2 (or Karnofsky performance status ≥ 60%).
  • Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,500/mcL
  • Platelets ≥100,000/mcL
  • Total bilirubin ≤ 1.5 X institutional ULN
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
  • Creatinine ≤ 1.5 X institutional ULN OR
  • Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5 X institutional ULN [in this circumstance, either of a measured level based on a 24 hour urine collection, or a calculated level using the Cockcroft and Gault equation: (140 - age in years) X (weight in kg) X (0.85 if female)/72 X serum Cr may be used].
  • International normalized ratio (INR) ≤ 1.5 (or in range INR, usually between 2 and 3, if patient is on a stable dose of therapeutic warfarin).
  • *ULN = upper limit of normal
  • **unless liver metastasis present in which AST/ALT should be < 5 x ULN.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Age 21 years old or older.

Who cannot join

  • Patients may not be receiving any other investigational agents.
  • Patients with known history of active intraparenchymal brain metastasis within previous 3 months.
  • Serious or non-healing wound, ulcer, or bone fracture.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
  • Patients with a reported history of clinically active diverticulosis or diverticulitis in the prior 3 years.
  • Patients with clinically significant cardiovascular disease as defined by the following:
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  • History of CVA within past 6 months
  • Myocardial infarction, CABG or unstable angina within past 6 months
  • New York Heart Association grade III or greater congestive heart failure or Canadian Cardiovascular Class grade III or greater angina within past 6 months (Appendices B\&C) Clinically significant peripheral vascular disease within past 6 months
  • Pulmonary embolism, DVT, or other thromboembolic event within past 6 months
  • Uncontrolled coronary artery disease, angina, congestive heart failure, or ventricular arrhythmia requiring acute medical management within past 6 months
  • History of myocardial infarct, cerebrovascular accident, or transient ischemic event within the past 6 month
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • While the use of Angiotensin-Converting Enzyme (ACE) inhibitors is not absolutely excluded, efforts should be made to see if patients on ACE inhibitors can be taken off the medication or switched to another medication.
  • Pregnant women will be ineligible; breastfeeding should be discontinued if the mother is treated with study drugs.
  • The use of agents that inhibit or induce CYP3A metabolism is not strictly prohibited, but should be avoided if possible. Potential CYP3A inducing agents include carbamazepine, phenytoin, barbiturates, rifabutin, rifampicin, and St. John's Wort. Potential CYP3A inhibitors include protease inhibitors, antifungals, macrolide antibiotics, nefazodone, and selective serotonin inhibitors.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan-Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan-Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan-Kettering at Mercy Medical Center

    Rockville Centre, New York

  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: Phase II Study Evaluating the Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer

The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer.

Temsirolimus is an intravenous medication that is FDA approved for other type of cancers. In laboratory studies, the addition of temsirolimus to sorafenib works better than sorafenib alone.

Conditions
Thyroid Cancer
Being tested
Temsirolimus and Sorafenib
Keywords
thyroid, follicular cell, papillary cell, Hurthle cell, BAY 43-9006, Temsirolimus, Sorafenib, 09-148
Medical subject headings
Thyroid Neoplasms, Thyroid Diseases

What participants receive

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

  • Temsirolimus and SorafenibDrug

    Treatment will be with sorafenib 200 mg orally twice a day and temsirolimus 25 mg intravenous weekly. A cycle will be equivalent to 4 weeks of treatment.

Study groups in NCT01025453
Study groupRoleWhat they receive
Pts getting Temsirolimus and SorafenibExperimentalWe propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay > 4 weeks, or at the discretion of the treating physician or patient.
Receives: Drug: Temsirolimus and Sorafenib

What is being measured

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

  1. Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: 2 years

Secondary outcomes (3)

  1. Duration of Study Treatment for Participants With and Without BRAF Mutations

    Measured: 6 years

  2. Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 1 year

  3. Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.

    Participant toxicities evaluated by CTCAE version 4.0

    Measured: 3 years

Timeline

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

  1. First posted3 Dec 2009 (estimated)
  2. Study start1 Dec 2009
  3. Primary completion16 Jan 2018
  4. Study completion16 Jan 2018

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01025453
Sponsor's protocol ID
09-148
Status last verified
Jul 2018
First submitted
2 Dec 2009
Last updated
15 Aug 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temsirolimus and Sorafenib in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 24 inclusion and 16 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: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 15 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer. (time frame: 2 years). 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 NCT01025453.

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 15 Aug 2018.

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