Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00387335
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00387335
Study Brief:
Protocol Section:
NCT00387335