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

Inclusion 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