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Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery Clinical research trials and Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery. Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery clinical trial. Test subjects typically receive the most effective healthcare possible for their Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery  Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
For Condition: high-grade salivary gland carcinoma,Salivary Gland Cancer,low-grade salivary gland carcinoma
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarshallPosner, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Marshall Posner 617-632-3090
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Philip Amrein 617-726-8748
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Everett Vokes 773-834-3093
Additional Information:
Study ID Numbers: CDR0000066863; DFCI-98168,LILLY-DFCI-98168,NCI-G99-1496
Study Start Date:
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003744
Other Salivary Gland Cancer Studies:
1. Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Related Studies:
Other Salivary Gland Cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
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