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Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003744
  Purpose

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

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders
Drug Information available for: Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Gemcitabine for Advanced Salivary Cancer: A Phase II Study

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: January 1999
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003744

Locations
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
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Marshall R. Posner, MD Dana-Farber Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009