CompletedPhase 2

Thyroid Cancer and Sunitinib

France71 participantsStarted 2007-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

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

Timeframe: Every two cycles

Trial details

NCT IDNCT00510640

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03