Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

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 gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck.

OBJECTIVES:

* Assess the therapeutic activity of gemcitabine, in terms of objective response and duration of response, in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck.
* Determine the acute toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 weeks until disease progression and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic or recurrent adenoid cystic carcinoma of the head and neck for which no curative options exist

  * Symptomatic and/or progressive disease
* At least 1 unidimensionally measurable lesion

  * At least 20 mm by conventional techniques OR
  * At least 10 mm by spiral CT scan
  * No bone metastases as only lesion
  * Prior radiotherapy to only target lesion allowed if it has progressed or reappeared after radiotherapy
* No CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic:

* Bilirubin no greater than 1.25 times upper limit of normal (ULN) (2.5 times ULN if liver metastases present)
* AST or ALT less than 3 times ULN (5 times ULN if liver metastases present)

Renal:

* Creatinine no greater than 1.7 mg/dL

Other:

* No uncontrolled infection
* No concurrent serious systemic disorders that would preclude study
* No other prior or concurrent malignancy except:

  * Adequately treated carcinoma in situ of the cervix
  * Basal cell or squamous cell skin cancer
  * Any malignancy that occurred more than 5 years ago with no symptoms or signs of recurrence (except malignant melanoma, hypernephroma, or breast carcinoma)
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy

Chemotherapy:

* No prior chemotherapy
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent anti-estrogen therapy
* Concurrent steroid replacement or steroids as an antiemetic allowed

Radiotherapy:

* See Disease Characteristics
* At least 3 months since prior radiotherapy except for palliative radiotherapy to bone lesions
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* At least 1 month since prior investigational agents
* No other concurrent experimental medications