SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity; Stage IVA Salivary Gland Cancer; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Salivary Gland Cancer; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Salivary Gland Cancer; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Carcinoma, Verrucous; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Paranasal Sinus Neoplasms; Neoplasms, Unknown Primary; Laryngeal Diseases; Recurrence
Intervention: ispinesib; laboratory biomarker analysis; pharmacological study
Intervention description: Given IV; Correlative studies; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well SB-715992 works in treating patients with recurrent
      or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in
      different ways to stop tumor cells from dividing so they stop growing or die.
    

Eligibility criteria:

        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

        Exclusion Criteria:

          -  Patients with non-squamous cell carcinomas of the head and neck or nasopharyngeal
             cancer

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from AEs due to agents administered more than 4 weeks earlier

          -  Patients may not have received any other investigational agents within 28 days of
             study entry

          -  Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or
             hormonal other than for replacement) while on this study

          -  The following lists of medications/substances are moderate to significant
             inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may
             alter study drug exposure; the use of these medications/substances within 14 days (>=
             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