Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenoid cystic carcinoma, salivary gland poorly differentiated carcinoma, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, salivary gland malignant mixed cell type tumor, salivary gland adenocarcinoma, salivary gland anaplastic carcinoma, salivary gland squamous cell carcinoma
Eligibility 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
Sites / Locations
- CancerCare Manitoba
- London Regional Cancer Program at London Health Sciences Centre
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital