Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 1999|
|Trial size||60 participants|
|Trial identifier||NCT00003744, CDR0000066863, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced salivary gland cancer that cannot be removed during surgery.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Chicago, IL||University of Chicago Cancer Research Center||no longer recruiting|
|Boston, MA||Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||no longer recruiting|
|Boston, MA||Massachusetts General Hospital Cancer Center||no longer recruiting|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically diagnosed metastatic salivary gland cancer including: - Adenoid cystic carcinoma - Mucoepidermoid carcinoma - Acinic cell carcinoma - Malignant mixed tumor - Polymorphous low grade adenocarcinoma - Undifferentiated carcinoma - Squamous cell carcinoma - Adenocarcinoma - Local or distant metastases - Unresectable tumor - Unidimensionally measurable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 2000/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 8.5 g/dL OR - Hematocrit greater than 25% Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - AST less than 2 times ULN (less than 5 times ULN if liver involved) - Alkaline phosphatase less than 5 times ULN (no limit if liver involved) Renal: - Creatinine less than 1.5 times ULN OR - Creatinine clearance at least 50% of lower limit of normal Cardiovascular: - No congestive heart failure Pulmonary: - No chronic obstructive pulmonary disease Other: - At least 3 years since prior invasive neoplasm except: - Nonmelanoma skin cancer - Cervical cancer - Not pregnant or nursing - Fertile patients must use effective contraception - No other significant active illness (e.g., uncontrolled diabetes, AIDS) PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 28 days since prior immunotherapy - No concurrent immunotherapy Chemotherapy: - No prior cytotoxic chemotherapy for disease - No other concurrent chemotherapy Endocrine therapy: - At least 28 days since prior hormone therapy - No concurrent hormone therapy Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - At least 28 days since prior homeopathic, natural, or alternative therapies - No concurrent homeopathic, natural, or alternative therapies
|Official title||Gemcitabine for Advanced Salivary Cancer: A Phase II Study|
|Description||OBJECTIVES: - Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine. - Evaluate the time to progression and toxicity of this therapy in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV for 30 minutes on days 1, 8, and 15 of each 28 day course. Patients receive a minimum of 2 courses of treatment. Patients may continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: This study will accrue a total of 16-60 patients.|
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