Status:
COMPLETED
Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by blocking some of th...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00387335
Start Date
August 1 2006
End Date
March 1 2010
Last Update
July 25 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637