Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck
Condition: Head and Neck Cancer; 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; Salivary Gland Squamous Cell Carcinoma; Stage IV Salivary Gland Cancer; 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 Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral 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: lapatinib ditosylate; capecitabine
Intervention description: Given orally; Given orally
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib
      ditosylate together works in treating patients with squamous cell cancer of the head and
      neck.
    

Eligibility criteria:

        Inclusion

          -  Histologically or cytologically confirmed SCCHN

          -  All primary sites are eligible excluding nasopharyngeal

          -  Metastatic disease or locally recurrent disease not felt amenable to curative therapy
             (as determined by a physician)

          -  ECOG performance status 0-2

          -  No prior chemotherapy in the metastatic / locally advanced, recurrent incurable
             setting; patients may have received prior curative-intention chemotherapy including
             induction chemotherapy, chemotherapy concurrent with radiation and adjuvant
             chemotherapy

          -  No prior capecitabine; patients who have received 5-FU or other fluoropyrimidines in
             the curative-intention setting will not be excluded, as long as more than 6 mos have
             elapsed since prior 5-FU exposure

          -  No previous history of Lapatinib

          -  Previous use of cetuximab in the curative-intention setting will not result in
             exclusion, as long as at least four weeks have elapsed since prior C225 exposure

          -  Patients may have received radiation therapy in the definitive, adjuvant or metastatic
             setting; radiation therapy must be completed at least 14 days prior to study
             participation

          -  ECOG performance status of 0-2 (Karnofsky >= 60%)

          -  Must have normal organ and marrow function

          -  Laboratory tests should be completed within 14 days prior to registration

          -  Left ventricular ejection fraction (LVEF) can be determined by either echocardiography
             or nuclear scintigraphy and should be obtained within 21 days of enrollment

          -  Platelets >= 100,000/mm^3

          -  Total bilirubin =< 2

          -  Albumin > 2.5

          -  AST(SGOT)/ALT(SGPT) =< 5.0 X institutional upper limit of normal (for patients with
             hepatic metastases) =< 3.0 X institutional upper limit of normal (for patients without
             hepatic metastases)

          -  GFR > 30 (by standard Cockroft and Gault formula)

          -  LVEF >= 50%

          -  Patients may receive anticoagulant medication while on study

          -  Patients may not receive other antineoplastic therapies such as chemotherapy or
             radiation treatments while on study; patients may not receive other experimental
             treatments while on study; patients requiring radiation treatments during
             protocol-based treatment will be taken off study

          -  Patients may receive concurrent bisphosphonate therapy as well as hormonal
             manipulations for appetite while on study

          -  Patients must neither be pregnant nor expect to become pregnant while on study

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

          -  Adequate swallowing function or gastric-tube for drug administration

          -  No disability with absorption of internal medications

          -  Adequate nutritional status: Patients will not be excluded based on previous weight
             loss but will be required to have adequate nutrition at the time of study entry as
             measured by serum albumin

          -  ANC >= 1,500/mm^3

          -  Women of child-bearing potential and men must agree to use adequate contraception
             prior to study entry and for the duration of study participation

        Exclusion

          -  Patients who have received prior capecitabine chemotherapy or lapatinib

          -  Patients with brain metastases may participate if they have undergone appropriate
             treatment for the lesion(s), are at least two weeks post treatment without evidence
             for post-treatment progression, have no significant neurologic symptoms, and are no
             longer on steroids for brain metastases

          -  Patients with symptoms concerning for CNS metastases should be evaluated with imaging
             prior to study participation

          -  Less than 3 weeks elapsed since prior exposure to chemotherapy

          -  LVEF < 50% or symptomatic congestive heart failure (CHF)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection requiring IV antibiotics, 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 due to the potential for teratogenic or abortifacient
             effects of capecitabine and lapatinib; because there is a potential risk for adverse
             events in nursing infants secondary to treatment of the mother with these agents,
             breastfeeding should be discontinued prior to participation of the mother on study

          -  Other active, invasive malignancy requiring ongoing therapy or expected to require
             systemic therapy within two years; localized squamous cell carcinoma of the skin,
             basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other
             malignancies requiring locally ablative therapy only will not result in exclusion

          -  Have received treatment within the last 30 days prior to study entry with any drug
             that has not received regulatory approval for an indication at the time of study entry

          -  Previous CHF or other cardiac conditions shall not result in exclusion if the treating
             physician does not see contraindication to these medications; if contraindication is
             controversial, cardiac consultation will be obtained prior to the initiation of
             therapy

          -  Anti-cancer therapy (other than the investigational regimen) is prohibited from 3
             weeks before the first dose of investigational product through discontinuation unless
             otherwise noted

          -  Investigational drugs are not permitted from 3 weeks (21 days) or 5 half-lives,
             whichever is longer, prior to the first dose and up through 30 days after the last
             dose of investigational product

          -  CYP3A4 inducers and inhibitors, antacids, and herbal or dietary supplements

          -  Concurrent radiation therapy and surgery for SCCHN is prohibited during therapy