s0618 e7389 in treating patients with metastatic or recurrent head and neck cancer

Conditions: Head and Neck Cancer

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.

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

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