Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields

Date de début de l'étude : 1 mai 2001

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