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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003744 |
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.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Gemcitabine for Advanced Salivary Cancer: A Phase II Study |
Estimated Enrollment: | 60 |
Study Start Date: | January 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically diagnosed metastatic salivary gland cancer including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
At least 3 years since prior invasive neoplasm except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 |
Study Chair: | Marshall R. Posner, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000066863, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003744 |
Health Authority: | United States: Federal Government |
stage III salivary gland cancer stage IV salivary gland cancer salivary gland squamous cell carcinoma salivary gland acinic cell tumor low-grade salivary gland mucoepidermoid carcinoma high-grade salivary gland mucoepidermoid carcinoma |
salivary gland adenocarcinoma salivary gland poorly differentiated carcinoma salivary gland anaplastic carcinoma salivary gland malignant mixed cell type tumor salivary gland adenoid cystic carcinoma |
Mouth Diseases Squamous cell carcinoma Mouth Neoplasms Adenoid cystic carcinoma Carcinoma Salivary Gland Neoplasms Epidermoid carcinoma Carcinoma, Adenoid Cystic |
Oral cancer Head and Neck Neoplasms Carcinoma, squamous cell Stomatognathic Diseases Gemcitabine Carcinoma, Squamous Cell Adenocarcinoma Salivary Gland Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |