Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

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

Marshall R. Posner

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003744
Information obtained from ClinicalTrials.gov on December 14, 2011

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