Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor

OBJECTIVES:

Primary

• Determine the activity of cisplatin or carboplatin in combination with gemcitabine, in terms of response rate, in patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor.

Secondary

• Determine the complete response in patients treated with these regimens.
• Determine the duration of response in patients treated with these regimens.
• Determine the toxicity profile of these regimens in these patients.
• Determine the overall survival of patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive either cisplatin IV over 1 hour on day 2 OR carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months thereafter until relapse.

PROJECTED ACCRUAL: A total of 11- 34 patients will be accrued for this study within 1.5-3 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed malignant salivary gland tumor

• All histological subtypes eligible
• Locally advanced, recurrent, or metastatic disease
• Considered incurable by radiotherapy or surgery
• Low- to intermediate-grade mucoepidermoid tumor or acinic cell carcinoma allowed provided patients are symptomatic OR at imminent risk of developing symptoms attributable to metastatic disease
• Disease must meet 1 of the following criteria:

• Metastatic disease that is chemonaïve
• Metastatic disease that has progressed after a prior non-cisplatin/carboplatin/gemcitabine regimen
• Local and/or distant recurrence after curative surgery and/or radiotherapy
• Locally advanced disease not suitable for surgery or radiotherapy
• At least 1 site of unidimensionally measurable disease documented by 1 of the following:

• At least 20 mm by X-ray, physical exam, or non-spiral CT scan
• At least 10 mm by spiral CT scan
• No bone metastases as only site of measurable disease
• No known brain metastasis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• AST/ALT no greater than 3 times upper limit of normal

Renal

• Creatinine clearance at least 60 mL/min (for cisplatin) OR 30-59 mL/min (for carboplatin)

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other serious illness or medical condition that would preclude study participation
• No active uncontrolled infection
• No neurologic disorder or psychiatric illness that would preclude study compliance
• No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy for locally advanced, recurrent, or metastatic disease and recovered

• Must have been a non-cisplatin/carboplatin/gemcitabine-containing regimen
• More than 12 months since prior adjuvant chemotherapy (including cisplatin/carboplatin-based regimens) and recovered
• No prior gemcitabine

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to only site of measurable disease unless there is documented disease progression after therapy

Surgery

• See Disease Characteristics
• At least 21 days since prior surgery and recovered

Other

• More than 30 days since prior anticancer therapy
• More than 30 days since prior investigational agents
• No other concurrent anticancer therapy
• No other concurrent investigational agents