Clinical trial NCT00077103 (phase 1/phase 2, status: terminated)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: cisplatin, doxorubicin hydrochloride, fosbretabulin disodium
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, COC1=CC(=CC(OC)=C1OC)[C@@H](O)CC1=CC(O)=C(OC)C=C1
Reason stopped: 
    slow accrual
  
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