RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced salivary gland cancer that cannot be removed during surgery.

Condition	Treatment or Intervention	Phase
high-grade salivary gland carcinoma low-grade salivary gland carcinoma Salivary Gland Cancer	Drug: gemcitabine  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

Marshall R. Posner, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000066863; DFCI-98168; LILLY-DFCI-98168; NCI-G99-1496
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003744
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08