Thyroid Cancer and Sunitinib

NCT00510640 | Completed Phase 2 DMC

• 1 other identifier: CHUBX 2006/23
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 15

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.

Conditions

Cancer; Thyroid Carcinoma

Keywords

thyroid carcinoma; Sunitinib; RECIST guidelines

Outcome Measures

Primary Outcomes (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

  Every two cycles

Secondary Outcomes (2)

• Evaluate the safety of sunitinib in patients with thyroid carcinoma

  After each cycle of treatment

• Determine time-to-event variables of overall survival, time to: disease progression, response, and duration of response

  variable

Study Arms (1)

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

Interventions

Sunitinib DRUG

Capsule, 12.5 or 50 mg, starting dose level 50 mg daily

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Pfizer: collaborator

Study Sites (15)

Centre Paul Papin - 2 rue Moll

Angers, 49100, France

Location

Département Endocrinolo-Diabéto-Nutrition - CHU d'Angers - 4 rue de Larray

Angers, 49933, France

Location

Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André - 1 rue Jean Burguet

Bordeaux, 33075, France

Location

Fédération Endocrinologie - Groupe Hospitalier Est - Hôpital neurologique - CHU Lyon - 59 Boulevard Pinel

Bron, 69677, France

Location

Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette - rue du Pr Laguesse

Lille, 59037, France

Location

Centre Léon Bérard - Département de Médecine - 28 rue Laennec

Lyon, 69373, France

Location

Service d'Endocrinologie, CHU Timone, AP-HM - 254 rue St Pierre

Marseille, 13385, France

Location

Service des Maladies Endocriniennes - Hôpital Lapeyronie - 191 avenue du Doyen Gaston Giraud

Montpellier, 34295, France

Location

Centre Paul Lamarque - Va d'Aurelle - CRLC Val d'Aurelle - 208 rue des Apothicaires

Montpellier, 34298, France

Location

Centre Antoine Lacassagne - 33 avenue de Valombrose

Nice, 06189, France

Location

Service d'Endocrinologie - Hôpital de l'Archet I - Route Saint Antoine de Jinestière

Nice, 06202, France

Location

Service de Cancérologie Médicale - HEGP - 20 rue Leblanc

Paris, 75015, France

Location

Service d'Oncologie Médicale, Institut Claudius Regaud - 20-24 rue du Pont Saint Pierre

Toulouse, 31052, France

Location

Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU Toulouse - avenue Prof Jean Poulhes

Toulouse, 31059, France

Location

Service d'Endocrinologie - CHU de Nancy, Hôpital de Brabois - rue du Morvan

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (2)

• Ravaud A, de la Fouchardiere C, Caron P, Doussau A, Do Cao C, Asselineau J, Rodien P, Pouessel D, Nicolli-Sire P, Klein M, Bournaud-Salinas C, Wemeau JL, Gimbert A, Picat MQ, Pedenon D, Digue L, Daste A, Catargi B, Delord JP. A multicenter phase II study of sunitinib in patients with locally advanced or metastatic differentiated, anaplastic or medullary thyroid carcinomas: mature data from the THYSU study. Eur J Cancer. 2017 May;76:110-117. doi: 10.1016/j.ejca.2017.01.029. Epub 2017 Mar 20.

  PMID: 28301826 RESULT

• Ravaud A, de la Fouchardiere C, Asselineau J, Delord JP, Do Cao C, Niccoli P, Rodien P, Klein M, Catargi B. Efficacy of sunitinib in advanced medullary thyroid carcinoma: intermediate results of phase II THYSU. Oncologist. 2010;15(2):212-3; author reply 214. doi: 10.1634/theoncologist.2009-0303.

  PMID: 20189981 RESULT

MeSH Terms

Conditions

Neoplasms; Thyroid Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alain Ravaud, Pr.

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Geneviève Chene, Pr.

  University Hospital, Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 14, 2026

Record last verified: 2013-02

Locations

FR (15)