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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00906360
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, meeting any of the following criteria:
* Recurrent disease
* Second primary locoregional recurrence\* with no clinically measurable distant disease
* Poor prognosis non-metastatic head and neck carcinoma (M0)
* Must have undergone radiotherapy as a component of prior treatment
* Not a candidate for surgical resection with curative intent
* Patients with high-risk features at resection or following resection for recurrence are eligible
* Must have locoregional tumor amenable to radiotherapy or reirradiation with curative intent
* Entire gross tumor recurrence volume must be able to be treated without exceeding a cumulative spinal cord dose of 50 Gy
* Unresected tumors must be measurable according to RECIST
* No known brain metastases
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* WBC ≥ 3,000/mm\^³
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* INR and PTT ratio \< 1.5
* AST and ALT ≤ 2.5 times ULN
* Creatinine normal OR creatinine clearance \> 60 mL/min
* Urine protein no more than trace
* Hematocrit ≥ 28%
* Hemoglobin ≥ 9 g/dL
* QTc \< 500 msec
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* The following patients are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO and MUGA:
* Asymptomatic on treatment
* Prior anthracycline exposure
* Prior central thoracic radiotherapy included the heart in the radiotherapy port
* No clinical evidence of active infection of any type, including hepatitis B or C virus
* Infections controlled with therapy are allowed
* Patients with hepatitis B or C on antiviral therapy with no detectable virus are allowed
* No immune deficiency and/or HIV positivity
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
* No gastrointestinal tract disease or condition, including any of the following, that impairs ability to retain sunitinib tablets:
* Inability to take oral medication or a requirement for IV alimentation
* Prior surgical procedures affecting absorption
* Active peptic ulcer disease
* None of the following conditions allowed:
* Serious or nonhealing wound, ulcer, or bone fracture
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial
* No active carotid artery involvement
* No history of documented thrombosis (pulmonary embolism within the past 12 months or deep vein thrombosis \[DVT\] within the past 6 months), known coagulopathies or thrombophilia, or evidence of DVT/thromboembolic event
* No history of the following cardiovascular conditions :
* Myocardial infarction within the past 12 months
* Cardiac arrhythmia or serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia ≥ 3 beats in a row) within the past 12 months
* Stable/unstable angina within the past 12 months
* Symptomatic congestive heart failure within the past 12 months
* Coronary/peripheral artery bypass graft or stenting within the past 12 months
* No cerebral vascular disease, cerebrovascular accident (stroke), or transient ischemic attack within the past 6 months
* QTc prolongation (QTc interval ≥ 500 msec)
* New York Heart Association class III-IV congestive heart failure
* Poorly controlled hypertension (i.e., systolic blood pressure \[BP\] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
* Other significant ECG abnormalities
* See Disease Characteristics
* Recovered from all prior radiotherapy and chemotherapy
* More than 4 months since prior radiotherapy to the head and neck
* More than 2 weeks since prior hormone replacement therapy or hormonal contraceptives
* More than 4 weeks since prior and no other concurrent investigational agents
* At least 1 month since prior surgery (unless ambulatory within 48 hours)
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
* Azole antifungals (ketoconazole, itraconazole)
* Clarithromycin
* Erythromycin
* Diltiazem
* Verapamil
* HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
* Delavirdine
* At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
* Rifampin
* Rifabutin
* Carbamazepine
* Phenobarbital
* Phenytoin
* St. John wort
* Efavirenz
* Tipranavir
* Concurrent coumarin-derivative anticoagulants (e.g., warfarin up to 2 mg daily) allowed for prophylaxis of thrombosis
* Concurrent use of medications known to affect the conductive system (e.g., beta-blockers, calcium channel blockers, or digoxin) allowed under investigator supervision
* No concurrent agent with proarrhythmic potential, including any of the following:
* Terfenadine
* Quinidine
* Procainamide
* Disopyramide
* Sotalol
* Probucol
* Bepridil
* Haloperidol
* Risperidone
* Indapamide
* Flecainide
* No concurrent chronic steroid treatment for \> 6 months (i.e., prednisolone doses \> 10 mg/day or equivalent)
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent amifostine
* No concurrent commercial agent or therapy intended to treat head and neck cancer
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00906360
Study Brief:
Protocol Section:
NCT00906360