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Phase 2 N=63 Treatment

Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery

Differentiated Thyroid Gland Carcinoma · Recurrent Thyroid Gland Carcinoma · Refractory Thyroid Gland Carcinoma · Stage III Thyroid Gland Follicular Carcinoma AJCC v7 · Stage III Thyroid Gland Medullary Carcinoma AJCC v7

Enrolled (actual)
63
Serious AEs
46.0%
Results posted
Sep 2017
Primary outcome: Primary: Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) — 9; 7 Participants — p=<0.10

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Pharmacogenomic Study (Other); Sunitinib (Drug); Sunitinib Malate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)
9; 7 <0.10
SECONDARY
Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0
38; 24
SECONDARY
Overall Survival
32.6; 65.4
SECONDARY
Time to Progression or Death Evaluated Using the RECIST
12.8; 19.3

Summary

This phase II trial studies how well sunitinib malate works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed papillary, follicular, or Hurthle cell carcinoma (cohort A) or medullary thyroid carcinoma (cohort B); their disease must have progressed despite treatment with iodine-131 therapy or they are not candidates for iodine-131 therapy and their disease cannot be completely removed by surgery; all patients with WDTC are expected to be on thyroxine suppression therapy
  • Patients must have radiographically or biochemically measurable disease; radiographically measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; biochemically measurable disease is defined as an elevated thyroglobulin (WDTC patients) or calcitonin (MTC patients)
  • Patients must have evidence of disease progression (objective growth of existing tumors or rising thyroglobulin or calcitonin levels) within the last 6 months
  • Patients cannot have received prior receptor tyrosine kinase inhibitors; patients cannot have received more than one prior chemotherapy regimen for metastatic disease; patients cannot have received prior external beam radiation to the measured tumor constituting the target lesion(s)
  • Life expectancy of greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%)
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9 g/dL
  • Serum calcium = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients must have corrected QT interval (QTc) < 500 msec
  • The following groups of patients are eligible provided they have New York Heart Association class II (NYHA) cardiac function on baseline echocardiogram (ECHO)/multigated acquisition scan (MUGA):
  • Those with a history of class II heart failure who are asymptomatic on treatment
  • Those with prior anthracycline exposure
  • Those who have received central thoracic radiation that included the heart in the radiotherapy port
  • The effects of sunitinib on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because antiangiogenic agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; all women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; at least 4 weeks must have elapsed since any major surgery
  • Patients may not be receiving any other investigational agents
  • Patients who have received prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, vascular endothelial growth factor [VEGF] Trap, etc.)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
  • Patients with QTc prolongation (defined as a QTc interval equal to or greater than 500 msec), serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia greater than or equal to 3 beats in a row) or other significant electrocardiogram (ECG) abnormalities are excluded
  • Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or dia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00381641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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