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Thyroid Cancer and Sunitinib (THYSU)
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, October 2007
Sponsors and Collaborators: University Hospital, Bordeaux
Pfizer
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00510640
  Purpose

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 Intervention Phase
Cancer
Thyroid Carcinoma
Drug: Sunitinib
Phase II

MedlinePlus related topics: Cancer Thyroid Cancer
Drug Information available for: Sunitinib malate Sunitinib Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 Measures:
  • Evaluate the safety of sunitinib in patients with thyroid carcinoma
  • Determine time-to-event variables of overall survival, time to: disease progression, response, and duration of response

Estimated Enrollment: 75
Study Start Date: August 2007
Estimated Study Completion Date: August 2011
Arms Assigned Interventions
Sunitinib: Experimental
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510640

Contacts
Contact: Alain Ravaud, Pr. 33 (0) 5 56 79 58 08 alain.ravaud@chu-bordeaux.fr

Locations
France
Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André Recruiting
Bordeaux, France, 33075
Contact: Alain Ravaud, Pr.     33 (0) 5 56 79 58 08     alain.ravaud@chu-bordeaux.fr    
Sub-Investigator: Bogdan Catargi            
Principal Investigator: Alain Ravaud            
Département Endocrinolo-Dabéto-Nutrition - CHU d'Angers Recruiting
Angers, France, 49933
Principal Investigator: Patrice Rodien            
Centre Paul Papin Not yet recruiting
Angers, France, 49100
Principal Investigator: Patrick Soulié            
Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette Not yet recruiting
Lille, France, 59037
Principal Investigator: Jean-Louis Wemeau            
Sub-Investigator: Christine Do Cao            
Centre Léon Bérard Recruiting
Lyon, France, 69373
Principal Investigator: Jean-Pierre Droz            
Sub-Investigator: Christelle De la Fouchardière            
Fédération Endocrinologie - Groupe Hopsitalier Est - Hôpital neurologique Recruiting
Bron, France, 69677
Principal Investigator: Françoise Borson-Chazot            
Sub-Investigator: Claire Bournaud            
CRLC Val d'Aurelle Recruiting
Montpellier, France, 34298
Principal Investigator: Stéphane Culine            
Service de Cancérologie Médicale Recruiting
Paris, France, 75015
Principal Investigator: Stéphane Oudard            
Sub-Investigator: Florian Scotte            
CHU de Nancy, Hôpital de Brabois Recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Marc Klein            
Sub-Investigator: Laurence Choné            
Service d'Endocrinologie - Hôpital de l'Archet I Not yet recruiting
Nice, France, 06202
Principal Investigator: Jean-Louis Sadoul            
Centre Antoine Lacassagne Not yet recruiting
Nice, France, 06189
Principal Investigator: Marc Frenay            
Service d'Oncologie Médicale, Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Principal Investigator: Jean-Pierre Delord            
Sub-Investigator: Frédéric Courbon            
Sub-Investigator: Marion Deslandres-Cruchant            
Sub-Investigator: Slimane Zerdoud            
Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU Not yet recruiting
Toulouse, France, 31059
Principal Investigator: Philippe Caron            
Service d'Endocrinologie, CHU Timone, AP-HM Recruiting
Marseille, France, 13385
Principal Investigator: Patricia Nicolli-Sire            
Service des Maladies Endocriniennes - Hôpital Lapeyronie Recruiting
Montpellier, France, 34295
Principal Investigator: Jacques Bringer            
Sub-Investigator: Eric Renard            
Sub-Investigator: Isabelle Raingeard            
Sponsors and Collaborators
University Hospital, Bordeaux
Pfizer
Investigators
Principal Investigator: Alain Ravaud, Pr. University Hospital, Bordeaux, France
Study Chair: Geneviève Chene, Pr. University Hospital, Bordeaux, France
  More Information

No publications provided

Study ID Numbers: 9277-06, 2006-023
Study First Received: August 1, 2007
Last Updated: October 25, 2007
ClinicalTrials.gov Identifier: NCT00510640  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:
thyroid carcinoma
Sunitinib
RECIST guidelines

Study placed in the following topic categories:
Thyroid Neoplasms
Sunitinib
Head and Neck Neoplasms
Endocrine System Diseases
Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009