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Thyroid Cancer and Sunitinib (THYSU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510640
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Cancer Thyroid Carcinoma Drug: Sunitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer
Study Start Date : August 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sunitinib
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.
Drug: Sunitinib
Capsule, 12.5 or 50 mg, starting dose level 50 mg daily

Primary Outcome Measures :
  1. 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 [ Time Frame: Every two cycles ]

Secondary Outcome Measures :
  1. Evaluate the safety of sunitinib in patients with thyroid carcinoma [ Time Frame: After each cycle of treatment ]
  2. Determine time-to-event variables of overall survival, time to: disease progression, response, and duration of response [ Time Frame: variable ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510640

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Centre Paul Papin - 2 rue Moll
Angers, France, 49100
Département Endocrinolo-Diabéto-Nutrition - CHU d'Angers - 4 rue de Larray
Angers, France, 49933
Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André - 1 rue Jean Burguet
Bordeaux, France, 33075
Fédération Endocrinologie - Groupe Hospitalier Est - Hôpital neurologique - CHU Lyon - 59 Boulevard Pinel
Bron, France, 69677
Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette - rue du Pr Laguesse
Lille, France, 59037
Centre Léon Bérard - Département de Médecine - 28 rue Laennec
Lyon, France, 69373
Service d'Endocrinologie, CHU Timone, AP-HM - 254 rue St Pierre
Marseille, France, 13385
Service des Maladies Endocriniennes - Hôpital Lapeyronie - 191 avenue du Doyen Gaston Giraud
Montpellier, France, 34295
Centre Paul Lamarque - Va d'Aurelle - CRLC Val d'Aurelle - 208 rue des Apothicaires
Montpellier, France, 34298
Centre Antoine Lacassagne - 33 avenue de Valombrose
Nice, France, 06189
Service d'Endocrinologie - Hôpital de l'Archet I - Route Saint Antoine de Jinestière
Nice, France, 06202
Service de Cancérologie Médicale - HEGP - 20 rue Leblanc
Paris, France, 75015
Service d'Oncologie Médicale, Institut Claudius Regaud - 20-24 rue du Pont Saint Pierre
Toulouse, France, 31052
Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU Toulouse - avenue Prof Jean Poulhes
Toulouse, France, 31059
Service d'Endocrinologie - CHU de Nancy, Hôpital de Brabois - rue du Morvan
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Alain Ravaud, Pr. University Hospital, Bordeaux, France
Study Chair: Geneviève Chene, Pr. University Hospital, Bordeaux, France
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Responsible Party: University Hospital, Bordeaux Identifier: NCT00510640    
Other Study ID Numbers: 9277-06
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013
Keywords provided by University Hospital, Bordeaux:
thyroid carcinoma
RECIST guidelines
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action