Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

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