OBJECTIVES:

• Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine.
• Evaluate the time to progression and toxicity of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV for 30 minutes on days 1, 8, and 15 of each 28 day course. Patients receive a minimum of 2 courses of treatment. Patients may continue treatment in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a total of 16-60 patients.

DISEASE CHARACTERISTICS:

• Histologically diagnosed metastatic salivary gland cancer including:

  • Adenoid cystic carcinoma
  • Mucoepidermoid carcinoma
  • Acinic cell carcinoma
  • Malignant mixed tumor
  • Polymorphous low grade adenocarcinoma
  • Undifferentiated carcinoma
  • Squamous cell carcinoma
  • Adenocarcinoma
• Local or distant metastases
• Unresectable tumor
• Unidimensionally measurable disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 2000/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin greater than 8.5 g/dL OR
• Hematocrit greater than 25%

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)
• AST less than 2 times ULN (less than 5 times ULN if liver involved)
• Alkaline phosphatase less than 5 times ULN (no limit if liver involved)

Renal:

• Creatinine less than 1.5 times ULN OR
• Creatinine clearance at least 50% of lower limit of normal

Cardiovascular:

• No congestive heart failure

Pulmonary:

• No chronic obstructive pulmonary disease

Other:

• At least 3 years since prior invasive neoplasm except:

  • Nonmelanoma skin cancer
  • Cervical cancer
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other significant active illness (e.g., uncontrolled diabetes, AIDS)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 28 days since prior immunotherapy
• No concurrent immunotherapy

Chemotherapy:

• No prior cytotoxic chemotherapy for disease
• No other concurrent chemotherapy

Endocrine therapy:

• At least 28 days since prior hormone therapy
• No concurrent hormone therapy

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• At least 28 days since prior homeopathic, natural, or alternative therapies
• No concurrent homeopathic, natural, or alternative therapies