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 =\< 1.5 X institutional upper limit of normal
• •AST(SGOT)/ALT(SGPT) =\< 3.0 X institutional upper limit of normal (=\< 5.0 X if liver metastases)
• •Creatinine =\< 1.5 X institutional upper limit of normal
• •Peripheral neuropathy may be no greater than grade 1
• •Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of SB-715992 will be determined following review of their use by the TREATING RESPONSIBLE investigator; patients receiving nonprohibited medications or substances known to interact with CYP450 isoenzymes may be eligible but should be monitored carefully; questions about eligibility related to concommitant use of medications should be discussed with the Principal Investigator
• •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
• •Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with SB-715992 is not expected
• •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •Ability to understand and the willingness to sign a written informed consent document