S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

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.

OBJECTIVES:

* Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389.
* Estimate progression-free and overall survival probability in these patients.
* Evaluate the qualitative and quantitative toxicities of this treatment regimen.

OUTLINE: This is a multicenter study.

Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

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