Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	DFCI-98168 LILLY-DFCI-98168, NCI-G99-1496, NCT00003744

Objectives

1. Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine.
2. Evaluate the time to progression and toxicity of this therapy in these patients.

Entry 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

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

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)

Expected Enrollment

This study will accrue a total of 16-60 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.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Marshall Posner, MD, Protocol chair		Ph: 617-632-3090; 866-790-4500 Email: marshall_posner@dfci.harvard.edu

Registry Information
Official Title		Gemcitabine for Advanced Salivary Cancer: A Phase II Study
Trial Start Date		1999-01-07
Registered in ClinicalTrials.gov		NCT00003744
Date Submitted to PDQ		1999-01-13
Information Last Verified		2004-08-26
NCI Grant/Contract Number		P30-CA06516

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