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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.
Study NCT00003744   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
January 1999
 
 
 
Complete list of historical versions of study NCT00003744 on ClinicalTrials.gov Archive Site
 
 
 
Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Gemcitabine for Advanced Salivary Cancer: A Phase II Study

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.

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.

Phase II
Interventional
Treatment
Head and Neck Cancer
Drug: gemcitabine hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003744
 
CDR0000066863, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Marshall R. Posner, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP