RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with either cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor (cancer).

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

Further Study Details: 

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.

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

Criteria

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

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting

Study chairs or principal investigators

Lillian L. Siu, MD, FRCPC,  Study Chair,  Princess Margaret Hospital   

Study ID Numbers:  CDR0000353487; CAN-NCIC-HN4; LILLY-CAN-NCIC-HN4; NCT00079079
Record last reviewed:  February 2004
Last Updated:  March 10, 2005
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079079
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08