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Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, 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, 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

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Trial Information

Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma


OBJECTIVES:

I. Determine the overall response rate of patients with recurrent and/or metastatic squamous
cell carcinoma of the head and neck treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of
administering this drug to patients with ECOG performance status 2 (cohort B).

OUTLINE: This is 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.

Inclusion Criteria


Criteria:

- Hemoglobin >= 9 g/dL

- 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

- 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/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- 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
requirement

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate (complete response [CR] and partial response [PR]) using RECIST criteria (cohort A)

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Ezra Cohen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00214

NCT ID:

NCT00387335

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • 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
  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Neoplasms, Unknown Primary
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470