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Sunitinib in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on September 26, 2006.   Last Updated on October 8, 2010   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00381641
  Purpose

RATIONALE: Sunitinib 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.

PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery.


Condition Intervention Phase
Head and Neck Cancer
Drug: sunitinib malate
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Sunitinib (SU11248) in Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers and Medullary Thyroid Cancers

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate to sunitinib malate in patients with iodine-refractory, unresectable well-differentiated thyroid cancer (WDCT) or medullary thyroid cancer (MTC) who have evidence of disease progression within the past 6 months.
  • Determine the toxicity of this drug in these patients.
  • Determine the duration of response, progression-free survival, and overall survival of patients with WDTC or MTC treated with this drug.

OUTLINE: This is an open-label, parallel-group, cohort, multicenter study. Patients are assigned to 1 of 2 cohorts according to type of thyroid cancer (medullary vs well-differentiated).

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Well-differentiated thyroid carcinoma (WDTC), including any of the following subtypes:

      • Papillary
      • Follicular
      • Hürthle cell
    • Medullary thyroid carcinoma (MTC)
  • Must show evidence of disease progression within the past 6 months despite treatment with iodine I 131 therapy OR ineligible for iodine I 131 therapy
  • Unresectable disease
  • Patients with WDTC must be receiving thyroxine suppression therapy
  • Measurable disease meeting 1 of the following criteria:

    • Radiographically measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
    • Biochemically measurable disease defined as an elevated thyroglobulin (WDTC patients) or calcitonin (MTC patients)
  • No known brain metastases

    • Patients with brain metastases with stable neurologic status after local therapy (surgery or radiotherapy) for ≥ 8 weeks from definitive therapy and without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events are eligible

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Calcium ≤ 12.0 mg/dL
  • Bilirubin normal
  • AST or ALT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5.0 times ULN if patient has liver metastases)
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
  • No poorly controlled hypertension, defined as systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg
  • No condition that would impair ability to swallow and retain sunitinib malate tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement of IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No pulmonary embolism within the past 12 months
  • QTc < 500 msec
  • No significant ECG abnormalities
  • No cerebrovascular accident or transient ischemic attack within the past 12 months
  • No myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic congestive heart failure, or coronary or peripheral artery bypass graft or stenting within the past 12 months
  • No New York Heart Association (NYHA) class III-IV heart failure or other condition
  • No serious ventricular arrhythmia (i.e., ventricular fibrillation or ventricular tachycardia ≥ 3 beats in a row)
  • Patients with any of the following conditions must have NYHA class II cardiac function confirmed on baseline ECHO/MUGA scan

    • History of class II heart failure and asymptomatic on treatment
    • Prior anthracycline exposure
    • Received central thoracic radiation that included the heart in the radiotherapy port
  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:

    • Ongoing or active infections
    • Psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No prior external-beam radiation to the measured tumor constituting the target lesion(s)
  • No prior receptor tyrosine kinase inhibitors
  • No prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, VEGF Trap)
  • At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 4 weeks since prior major surgery
  • No other concurrent anticancer agents or therapies
  • No other concurrent investigational agents
  • No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin

    • Doses ≤ 2 mg daily for prophylaxis of thrombosis allowed
    • Low molecular weight heparin allowed provided PT INR ≤ 1.5
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent enzyme-inducing anticonvulsants
  • No concurrent agents with proarrhythmic potential, including any of the following:

    • Terfenadine
    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:

    • Azole antifungals (e.g., ketoconazole, itraconazole)
    • Clarithromycin, erythromycin
    • Diltiazem
    • Verapamil
    • HIV-protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
    • Delavirdine
  • At least 12 days since prior and no concurrent inducers of CYP3A4, including any of the following:

    • Rifampin
    • Rifabutin
    • Carbamazepine
    • Phenobarbital
    • Phenytoin
    • Hypericum perforatum (St. John's wort)
    • Efavirenz
    • Tipranavir
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381641

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Missouri
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Ezra Cohen, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Everett E. Vokes, University of Chicago Cancer Research Center
ClinicalTrials.gov Identifier: NCT00381641     History of Changes
Other Study ID Numbers: CDR0000502260, UCCRC-14696A, NCI-7735
Study First Received: September 26, 2006
Last Updated: October 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
thyroid gland medullary carcinoma
stage IV follicular thyroid cancer
stage IV papillary thyroid cancer
recurrent thyroid cancer
stage II follicular thyroid cancer
stage II papillary thyroid cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Head and Neck Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012