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Gemcitabine for Advanced Salivary Cancer: A Phase II Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Gemcitabine for Advanced Salivary Cancer: A Phase II Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Marshall R. Posner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066863

NCT ID:

NCT00003744

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms
  • Salivary Gland Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115