S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: eribulin mesylate
Intervention description: 1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; 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; 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; untreated metastatic squamous neck cancer with occult primary; salivary gland squamous cell carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well E7389 works in treating patients with
      metastatic or recurrent head and neck cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
             (SCCHN)

               -  Disease is either metastatic at diagnosis or has persisted, metastasized, or
                  recurred after definitive surgery and/or radiotherapy

               -  Not amenable to surgical resection for salvage therapy

               -  No newly diagnosed nonmetastatic disease

               -  No salivary or nasopharyngeal primary disease

               -  Patients who have failed primary surgery alone, and who have disease that is
                  salvageable by radiation or chemoradiation, are not eligible

          -  Measurable disease

               -  Measurable disease within a previous radiotherapy port must demonstrate clearly
                  progressive disease

          -  No active or prior CNS metastasis

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Absolute granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  SGOT and SGPT ≤ 2 times ULN

          -  Creatinine ≤ 2 times ULN

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No known HIV positivity

          -  No prior malignancies except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  In situ cervical cancer

               -  Adequately treated stage I or II cancer currently in complete remission

               -  Any other cancer for which the patient has been disease free for ≥ 5 years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy for recurrent or newly diagnosed metastatic disease

          -  At least 6 months since prior induction or adjuvant chemotherapy for patients who
             relapsed after receiving this therapy

               -  No more than 1 prior induction or adjuvant regimen (may have included a taxane)

          -  More than 2 weeks since prior biologic therapy (i.e., epidermal growth factor
             inhibitors and vascular endothelial growth factor inhibitors)

          -  More than 28 days since prior radiotherapy and recovered

          -  More than 28 days since prior surgery and recovered

          -  No other concurrent therapy (i.e., radiotherapy, chemotherapy, immunotherapy, biologic
             therapy, or gene therapy) for SCCHN

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent prophylactic colony-stimulating factors during course 1