Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003744
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: August 2004
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Gemcitabine for Advanced Salivary Cancer: A Phase II Study

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003744     History of Changes
Other Study ID Numbers: CDR0000066863, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496
Study First Received: November 1, 1999
Last Updated: July 23, 2008
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014