Clinical trial NCT00060242 (phase 2, status: completed)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: fosbretabulin disodium
SMILES: COC1=CC(=CC(OC)=C1OC)[C@@H](O)CC1=CC(O)=C(OC)C=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed* anaplastic or poorly differentiated variant thyroid cancer,
             including 1 of the following:

               -  Recurrent/regionally advanced disease no longer amenable to definitive curative
                  surgery or radiotherapy

               -  Untreated metastatic disease NOTE: *If original/diagnostic tumor blocks are
                  unavailable, tumor must be accessible for pretreatment core needle biopsy

          -  Must have relapsed or progressed during or after prior combined modality therapy
             (e.g., systemic chemotherapy and radiotherapy) for regionally advanced (but not
             metastatic) disease

          -  Measurable or evaluable disease

          -  Patent trachea and airway by screening direct and indirect laryngoscopy* NOTE: *For
             patients with bulky thyroid/neck masses and/or suspected airway obstruction

          -  No active brain metastases, as evidenced by any of the following:

               -  Symptomatic involvement

               -  Cerebral edema by CT scan or MRI

               -  Radiographic evidence of progression since definitive therapy

               -  Continued requirement for corticosteroids

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 75,000/mm^3

          -  Hemoglobin at least 8.5 g/dL

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  ALT and AST no greater than 3.5 times ULN

        Renal

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular

          -  LVEF at least 50% by MUGA

          -  EKG normal

               -  No evidence of prior myocardial infarction (e.g., significant Q waves), QTc
                  greater than 450 msec, or other clinically significant abnormalities

          -  No history of angina (even if controlled by medication)

          -  No congestive heart failure

          -  No uncontrolled atrial arrhythmias

          -  No clinically significant arrhythmias, including any of the following:

               -  Conduction abnormalities

               -  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 MUGA

          -  No uncontrolled hypertension (blood pressure consistently greater than 150 mm Hg
             systolic and 100 mm Hg diastolic regardless of medication)

               -  Patients with previous hypertension are allowed provided there is clinical
                  documentation of controlled blood pressure for 2 months prior to study enrollment

          -  No symptomatic peripheral vascular disease

          -  No symptomatic cerebrovascular disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No grade 2 or greater preexisting motor or sensory peripheral neuropathy

          -  No uncontrolled hypokalemia or hypomagnesemia

          -  No concurrent serious infection

          -  No other nonmalignant medical illness that is uncontrolled or whose control may be
             jeopardized by study therapy

          -  No psychiatric disorders or other conditions that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent biologic therapy

          -  No concurrent immunotherapy

          -  No concurrent prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or
             sargramostim [GM-CSF])

        Chemotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

          -  No concurrent hormonal therapy, except any of the following:

               -  Gonadotropin-releasing hormone agonists for hormone-refractory prostate cancer

               -  Hormone replacement therapy

               -  Oral contraceptives

               -  Megestrol for anorexia/cachexia

        Radiotherapy

          -  See Disease Characteristics

          -  More than 4 weeks since prior radiotherapy with progressive disease beyond radiation
             ports

          -  No prior radiotherapy to more than 30% of the bone marrow

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

          -  More than 4 weeks since prior major surgery

        Other

          -  At least 6 weeks since other prior therapy associated with delayed toxicity

          -  No prior therapy for metastatic disease

          -  No concurrent medication(s) known to prolong the QTc interval, unless medication(s)
             can be held for at least 72 hours before, during, and for at least 6 hours after study
             drug administration

          -  No other concurrent investigational therapy

          -  No other concurrent antineoplastic or cytotoxic therapy