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