SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Patients must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck that is recurrent or metastatic; with the exception of the nasopharynx, all primary sites (including oral cavity, oropharynx, hypopharynx, and larynx) will be eligible; MedDRA disease terms:
• Oral neoplasms NOS, 10031008
• Oropharyngeal cancer recurrent, 10031098
• Hypopharyngeal cancer recurrent, 10021044
• Laryngeal cancer recurrent, 10023828
• Maxillofacial sinus neoplasm, 10026956
• Head and neck, 90002024
• Patients may have had a maximum of one prior chemotherapy regimen for recurrent or metastatic disease; patients may enter this study and receive SB-715992 as their first-line therapy for recurrent and/or metastatic disease; prior platinum-based chemotherapy delivered concurrently with radiotherapy, or prior platinum-based induction chemotherapy, is allowed; there must be at least a 4 week interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy - please contact the Principal Investigator (Dr. E. Winquist) PRIOR to registration if questions arise about the interpretation of this criterion; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
• Patients must have 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
• Life expectancy of greater than 12 weeks.
• ECOG performance status 0,1, or 2
• Leukocytes >= 3,000/uL
• Absolute neutrophil count >= 1,500/uL
• Platelets >= 100,000/uL
• Total bilirubin = = 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
• Inhibitors of CYP3A4:
• Antibiotics: clarithromycin, erythromycin, troleandomycin
• Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day), voriconazole
• Antidepressants: nefazodone, fluovoxamine
• Calcium channel blockers: verapamil, diltiazem
• Miscellaneous: amiodarone*, grapefruit juice, bitter orange
• Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited
• Inducers of CYP3A4:
• Anticonvulsants: phenytoin, carbamazepine, Phenobarbital, oxcarbazepine
• Antibiotics: rifampin, rifabutin, rifapentine
• Miscellaneous: St. John's wort, modafinil
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to SB-715992
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because SB-715992 is a mitotic inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SB-715992, breastfeeding should be discontinued if the mother is treated with SB-715992