A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors

Date de début de l'étude : 27 octobre 2003

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