liposomal lurtotecan in treating patients with metastatic or locally recurrent head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.

objectives: * determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck. * determine the objective response, duration of response, and time to progression in patients treated with this drug. * determine the toxicity profile of this drug in these patients. * determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients. outline: this is a multicenter study. patients are stratified according to presence of a target lesion in a previously irradiated field (within vs outside). patients receive lurtotecan liposome iv over 30 minutes on days 1 and 8. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 6 weeks. projected accrual: a total of 38-72 patients (19-36 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the head and neck * metastatic or loco-regionally recurrent disease * no undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas * no tumors of the nasal or paranasal cavities or of the nasopharynx * measurable disease * no clinical symptomatic evidence of brain or leptomeningeal metastases * ineligible for loco-regional treatment after chemotherapy patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * transaminases no greater than 2.5 times uln (5 times uln if liver metastases present) renal: * creatinine no greater than 1.5 times uln * no uncontrolled hypercalcemia other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 30 days after study * no known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug * no uncontrolled systemic disease or infection * no psychological, familial, sociological, or geographical condition that would preclude study * no other prior or concurrent malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer prior concurrent therapy: biologic therapy: * no concurrent anticancer biological therapy or immune response modifiers * no concurrent prophylactic hematopoietic growth factors chemotherapy: * see disease characteristics * no prior chemotherapy for recurrent disease * no prior therapy with camptothecin analogues * at least 8 weeks since prior neoadjuvant or adjuvant chemotherapy * no other concurrent anticancer cytotoxic therapy endocrine therapy: * not specified radiotherapy: * at least 8 weeks since prior radiotherapy and recovered surgery: * not specified other: * at least 30 days since prior experimental drug

Keywords: recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage iii squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage iii squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx