Thyroid Cancer and Sunitinib

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Brief Title

Thyroid Cancer and Sunitinib

Official Title

Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer

Brief Summary

      Due to arguments showing that angiogenesis could be involved in progression of metastatic
      thyroid carcinoma and to objective response during previous studies with sunitinib (an
      angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate
      the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard
      treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is
      limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment
      despite some use of chemotherapy.

      The objective of the trial is to determine the objective tumor response rate (efficacy) in
      patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid
      carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of
      sunitinib in these patients.

      The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75
      patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid
      carcinoma.
    

Detailed Description

      The THYSU trial is a phase II trial of sunitinib (Sutent) in patients with locally advanced
      or metastatic anaplastic, differentiated or medullary thyroid carcinoma.

      Due to arguments showing that angiogenesis could be involved in progression of metastatic
      thyroid carcinoma and to objective response during a phase I trial with sunitinib, it was
      justified to evaluate in a prospective trial the efficacy of sunitinib in metastatic thyroid
      carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general
      treatment is to be prescribed is limited to radioiodine. When radioiodine becomes
      ineffective, there is no standard treatment despite some usage of chemotherapy.

      The objective of the trial is to determine the objective tumor response rate in patients with
      locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma
      treated with sunitinib, a secondary objective is to evaluate the safety of sunitinib in these
      patients with thyroid carcinoma.

      The treatment of sunitinib is the standard dosage and schedule. Sunitinib is given orally at
      the dose of 50 mg daily for 28 days followed by 2 weeks of rest. Forthcoming cycles remain
      identical. Modification of the dose may use a lower dose at 37.5 mg or 25 mg given daily on
      the same schedule. All patients will receive repeated cycles of treatment until disease
      progression, occurrence of unacceptable toxicity, withdrawal of patient consent, or other
      withdrawal criteria are met. After discontinuation of treatment and the mandated 28-day
      follow up, patients will be followed only in order to collect information on further
      antineoplastic therapy and survival. In patients discontinuing treatment for reasons other
      than disease progression, tumor assessment will continue until disease progression, or
      initiation of other antineoplastic therapies.

      The more frequent side effects are asthenia, mucositis, arterial hypertension, hand foot
      syndrome and diarrhea. Other side effects have been reported including nausea, vomiting,
      cutaneous events, decrease in left ventricular ejection fraction, neutropenia, and
      thrombopenia.

      The patients must meet all of the following inclusion criteria to be eligible for enrollment
      into the trial:

        -  Patients must sign and date IRB/EC-approved informed consent.

        -  Age ≥ 18.

        -  Patients must have a life expectancy of at least 3 months and Karnofsky performance
           status ≥ 70%

        -  Patients must have histologically confirmed TC

        -  Tumor disease must be progressive (evidence of disease progression within 6 months)

        -  Patients should not be candidates for surgical resection, external beam radiotherapy or
           radioiodine, and patients must not have more than one previous systemic treatment for
           cancer

        -  Patients must have measurable disease defined by RECIST criteria as at least one lesion
           at least 2 cm in length by conventional CT techniques or at least 1 cm by spiral CT
           scan.

        -  Resolution of all acute toxic effects of any prior treatment to NCI - CTCAE (version
           3.0) grade < 1.

        -  Patients must have discontinued from radiation therapy at least 4 weeks before first
           dose of study treatment and must have recovered from any toxic effects of treatment.

        -  Blood pressure < 140 / 90 mmHg

        -  Patients must have adequate organ function.

        -  Patients with reproductive potential must use medically acceptable contraceptive method.

        -  Willingness and ability to comply with the study procedures.

        -  Patient affiliated with or profiting from a social security system

      The presence of any non-inclusion criteria will exclude a patient from study enrollment.

      Prior to undergoing any specific study procedures, patient and investigator sign informed
      consent. During the initial visit including verification of eligibility criteria, an
      interview with the patient is conducted regarding his/her recent and past clinical and
      treatment history (including oncology history). Physical examination including examination of
      major body systems, Karnofsky performance status, body weight, height, and vital signs is
      performed. Laboratory data are collected (hematology and chemistry, coagulation, thyroid
      tests, tumor markers and pregnancy test if applicable). Para clinic evaluations (12-lead ECGs
      and tumor imaging) are carried out. LVEF assessed by Echocardiogram or by MUGA scan (if
      necessary) and Brain Naturatic Peptide (Or NT pro-BNP) test are done.

      During the follow-up, the patients are followed between the end of week 4 and week 6 by
      clinical and biological evaluation. Evaluation of tumor sites under sunitinib is planned
      every 2 cycles with CT scans. For patients with anaplastic or differentiated thyroid
      carcinoma, the first stage will include 21 efficacy-evaluable patients. An additional 29
      efficacy-evaluable patients will be included at the second stage.

      For patients with medullary thyroid carcinoma, the first stage will include 11
      efficacy-evaluable patients. An additional 7 to 14 efficacy-evaluable patients will be
      included at the second stage.

      10 French Oncology Departments are involved in this trial.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate (ORR) : defined as the proportion of patients with confirmed complete (CR) or partial response (PR) according to the RECIST, relative to the total patients enrolled who received at least 1 dose of trial medication

Secondary Outcome

 Evaluate the safety of sunitinib in patients with thyroid carcinoma

Condition

Cancer

Intervention

Sunitinib

Study Arms / Comparison Groups

 Sunitinib
Description:  Sunitinib will be administered orally daily for 4 weeks followed by a 2-week rest; the daily starting dose will be 50 mg with a provision for dose reduction based on tolerability. All patients will receive repeated cycles until disease progression or occurrence of severe toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

71

Start Date

August 2007

Completion Date

March 2012

Primary Completion Date

March 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Signed informed consent.

          -  Age ≥ 18.

          -  Patients must have a life expectancy of at least 3 months

          -  Patients must have a Karnofsky performance status ≥ 70%

          -  Patients must have histologically confirmed thyroid cancer (TC)

          -  Tumor disease must be progressive (evidence of disease progression within 6 months
             before starting the study for follicular and medullary thyroid cancer or symptomatic
             disease)

          -  Patients should not be candidates for surgical resection, external beam radiotherapy
             or radioiodine

          -  Patients must have measurable disease defined by Response Evaluation Criteria in Solid
             Tumors (RECIST), such as at least one lesion at least 2 cm in length by conventional
             computed tomography (CT) techniques or at least 1 cm by spiral CT scan

          -  Patients must not have more than one previous systemic treatment for cancer

          -  Resolution of all acute toxic effects of any prior local treatment to National Cancer
             Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 3.0)
             grade < 1

          -  Patients must have discontinued from radiation therapy at least 4 weeks before start
             of study treatment and must have recovered from any toxic effects of treatment

          -  Blood pressure < 140 / 90 mmHg

          -  Patients must have adequate organ function defined as: Platelets > 100 x 10*9/L,
             Hemoglobin > 8 g/dl, ANC > 1.5 x 10*9/L, Bilirubin < 3 mg/dL, AST and ALT < 2.5 x the
             upper limit of normal (ULN) or < 5 x the ULN for liver metastases, INR < 1.7 or
             prothrombin time < 6 sec over ULN, Serum creatinine < 1.5 x ULN

          -  Patients with reproductive potential must use medically acceptable contraceptive
             methods (oral contraception or an intrauterine device [IUD])

          -  Willingness and ability to comply with all study procedures

          -  Affiliated or profit patient of a social security system

        Exclusion Criteria:

          -  Prior treatment on sunitinib or other anti-angiogenic therapy

          -  NCI CTCAE grade 3 hemorrhage < 4 weeks of starting study treatment

          -  Diagnosis of any second malignancy < 3 years, except basal cell carcinoma, squamous
             cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately
             treated with no evidence of recurrent disease for 12 months

          -  History of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis, or new evidence of brain or leptomeningeal disease

          -  Any of the following within the 12 months prior to study drug administration:
             severe/unstable angina, myocardial infarction, coronary artery bypass graft,
             symptomatic congestive heart failure, cerebrovascular accident, including transient
             ischemic attack, or pulmonary embolism

          -  Ongoing cardiac dysrhythmias of NCI CTCAE grade > 2, atrial fibrillation of any grade,
             or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females

          -  Left ventricular ejection fraction ( LVEF) < 50%

          -  Hypertension that cannot be controlled by medications

          -  Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin
             currently or within 2 weeks prior to first day of sunitinib administration

          -  Inability to swallow oral medications, or presence of active inflammatory bowel
             disease, partial or complete bowel obstruction or chronic diarrhea

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             (AIDS)-related illness

          -  Pregnancy or breastfeeding

          -  Other severe acute or chronic medical or psychiatric condition, or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the patient inappropriate for entry into
             this study

          -  Receipt of any investigational agent prior to study entry

          -  Current treatment on another therapeutic clinical trial

          -  Patient under safeguard of justice
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alain Ravaud, Pr., , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00510640

Organization ID

9277-06

Secondary IDs

2006-23

Responsible Party

Sponsor

Study Sponsor

University Hospital, Bordeaux

Collaborators

 Pfizer

Study Sponsor

Alain Ravaud, Pr., Principal Investigator, University Hospital, Bordeaux, France


Verification Date

February 2013