S0618 E7389 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.

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