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Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00387335
  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 how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer.


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

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Sunitinib Sunitinib malate Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma

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

Primary Outcome Measures:
  • Objective tumor response rate (complete response [CR] and partial response [PR]) (cohort A) [ Designated as safety issue: No ]
  • Feasibility of treatment in patients with ECOG performance status 2 (cohort B) [ Designated as safety issue: No ]
  • Tumor response (cohort B) [ Designated as safety issue: No ]
  • Progression-free and overall survival (cohort A) [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: May 2006
Estimated Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.
  • Determine the toxicity of this drug in these patients.
  • Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).

OUTLINE: This a multicenter, cohort study. Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 [cohort A] vs ECOG 2 [cohort B]).

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

After completion of study treatment, patients are followed periodically for at least 1 year.

PROJECTED ACCRUAL: A total of 43 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 squamous cell carcinoma of the head and neck

    • Recurrent and/or metastatic disease
  • Measurable disease, 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 CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 2 months
  • ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% (for patients in cohort A)
  • ECOG PS 2 or Karnofsky PS 60-70% (for patients in cohort B)
  • 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 and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • QTc < 500 msec
  • No New York Heart Association class III or IV heart failure

    • Patients with the following are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO/MUGA:

      • History of class II heart failure and asymptomatic on treatment
      • Prior anthracycline exposure
      • Prior central thoracic radiation that included the heart in the radiotherapy port
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions to compounds of similar chemical or biological composition to sunitinib malate
  • No history of serious ventricular arrhythmia (i.e., ventricular fibrillation or ventricular tachycardia ≥ 3 beats in a row)
  • No history of other significant ECG abnormalities
  • No uncontrolled hypertension (defined as systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
  • No condition resulting in an inability to take oral medication, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
    • Active peptic ulcer disease
  • No gastrostomy, jejunostomy, or other forms of enteral tube-feeding modalities
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No cerebrovascular accident or transient ischemic attack within the past 12 months
  • No myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
  • No pulmonary embolism within the past 12 months
  • No pre-existing uncontrolled thyroid abnormality (i.e., inability to maintain thyroid function within the normal range with medication)
  • No uncontrolled intercurrent illness, including either of the following:

    • Ongoing or active infection
    • Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • No more than two prior regimens for recurrent or metastatic disease

    • Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemoradiotherapy) is allowed and will not count as prior therapy for recurrent or metastatic disease
  • At least 4 weeks since prior major surgery
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 4 weeks since prior radiotherapy
  • No prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or VEGF Trap)
  • No prior surgical procedure affecting absorption
  • At least 7 days since prior and no concurrent use of CYP3A4 inhibitors, including any of the following:

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

    • Rifampin
    • Phenytoin
    • Rifabutin
    • Hypericum perforatum (St. John's wort)
    • Carbamazepine
    • Efavirenz
    • Phenobarbital
    • Tipranavir
  • No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)

    • Concurrent dosing of ≤ 2 mg of warfarin daily for prophylaxis of thrombosis is allowed
    • Concurrent low molecular weight heparin allowed provided prothrombin time INR is ≤1.5
  • No other concurrent investigational agents
  • No concurrent agents with proarrhythmic potential, including any of the following:

    • Terfenadine
    • Quinidine
    • Procainamide
    • Disopyramide
    • Sotalol
    • Probucol
    • Bepridil
    • Haloperidol
    • Risperidone
    • Indapamide
    • Flecainide
  • No other concurrent anticancer agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387335

Locations
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
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
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Ezra Cohen, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000504024, UCCRC-14701A, NCI-7738
Study First Received: October 12, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00387335  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary

Study placed in the following topic categories:
Squamous cell carcinoma
Recurrence
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Sunitinib
Head and Neck Neoplasms
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

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 January 16, 2009