• Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
  

• Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
  
• Toxicity as assessed by CTCAE weekly [ Designated as safety issue: Yes ]
  
• Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3 [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the tumor response rate in patients with unresectable locally advanced or metastatic incurable salivary gland cancer treated with capecitabine and oxaliplatin.

Secondary

• Determine time to disease progression in patients treated with this regimen.
• Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a positive response after 2 courses receive additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed salivary gland cancer, including the following histologies:

  • Adenoid cystic carcinoma
  • Mucoepidermoid carcinoma
  • Acinic cell carcinoma
  • Malignant mixed tumor
  • Polymorphous low-grade adenocarcinoma
  • Undifferentiated carcinoma
  • Squamous cell carcinoma
  • Adenocarcinoma

• Incurable disease

  • Unresectable local or distant disease

• At least 1 unidimensionally measurable lesion documented by physical exam or radiology within the past month

  • No prior radiotherapy to sites used for evaluation of response unless these sites demonstrate disease progression after completion of radiotherapy
• Not amenable to potentially curative radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count ≥ 2,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin > 8.5 g/dL
• Hematocrit > 25%

Hepatic

• Bilirubin < 2 times upper limit of normal (ULN)
• AST < 2 times ULN (5 times ULN with liver involvement)
• Alkaline phosphatase < 5 times ULN (no upper limit restriction with bone or liver involvement)

Renal

• Creatinine < 1.5 times ULN OR
• Creatinine clearance ≥ 50% of lower limit of normal on 24-hour urine collection

Cardiovascular

• No congestive heart failure

Pulmonary

• No chronic obstructive pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• Able to tolerate and swallow tablets OR undergo gastrointestinal tube insertion
• No uncontrolled diabetes
• No other significant active illness
• No other invasive malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or cervical cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 28 days since prior and no concurrent immunotherapy

Chemotherapy

• Prior adjuvant chemotherapy given with radiotherapy with curative intent allowed
• No prior cytotoxic chemotherapy for metastatic salivary gland cancer

Endocrine therapy

• More than 28 days since prior and no concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• See Chemotherapy
• More than 1 month since prior radiotherapy to sites used for evaluation of response
• No concurrent radiotherapy

Surgery

• Not specified

Other

• More than 28 days since prior and no concurrent homeopathic therapy
• More than 28 days since prior and no concurrent natural therapy
• More than 28 days since prior and no concurrent alternative medicine therapy
• No other concurrent anticancer therapy