RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine together with oxaliplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced or metastatic salivary gland cancer that cannot be removed by surgery.

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

Further Study Details: 

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.

Patients are followed every 3 months.

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

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

Criteria

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

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Robert I. Haddad, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000406025; DFCI-04149; SANOFI-DFCI-04149; NCT00101075
Record last reviewed:  December 2004
Last Updated:  February 4, 2005
Record first received:  January 7, 2005
ClinicalTrials.gov Identifier:  NCT00101075
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08