Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring anaplastic thyroid cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following: Regionally advanced disease Confined to the neck and/or superior mediastinum (i.e., above the level of the carina) Measurable or evaluable* disease Completely resected disease without measurable or evaluable disease NOTE: *At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 8.5 g/dL Hepatic Bilirubin ≤ 1.5 mg/dL ALT and AST ≤ 3.5 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL Cardiovascular LVEF ≥ 50% by echocardiogram EKG normal No prior angina No prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec, or other clinically significant abnormalities on ECG No congestive heart failure No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following: Conduction abnormality Nodal junctional arrhythmias and dysrhythmias Sinus bradycardia or tachycardia Supraventricular arrhythmias Atrial fibrillation or flutter Syncope or vasovagal episodes No significant heart wall abnormality or heart muscle damage by echocardiogram No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication) Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry No symptomatic peripheral vascular disease or cerebrovascular disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled hypokalemia or hypomagnesemia No concurrent serious infection No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy No grade 2 or greater pre-existing motor or sensory peripheral neuropathy No psychiatric disorder or other condition that would preclude study compliance No conditions associated with QTc prolongation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy No concurrent immunotherapy Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy, except for the following: Gonadotropin-releasing hormone agonists for patients with hormone-refractory prostate cancer Hormone replacement therapy Oral contraceptives Megestrol for anorexia/cachexia Radiotherapy No prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Prior attempt at resection or cytoreduction (e.g., debulking) surgery irrespective of surgical margins allowed provided there are no distant metastases At least 1 week but no more than 8 weeks since prior surgery and recovered Other No other concurrent cytotoxic therapy No other concurrent antineoplastic therapy No other concurrent investigational therapy No concurrent medications known to prolong the QTc interval unless the medication can be held for at least 4 days during each treatment course
Sites / Locations
- Josephine Ford Cancer Center at Henry Ford Hospital
- Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute