This trial is active, not recruiting.

Condition head and neck cancer
Treatment gemcitabine hydrochloride
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date January 1999
Trial size 60 participants
Trial identifier NCT00003744, CDR0000066863, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Gemcitabine for Advanced Salivary Cancer: A Phase II Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).