Spots Global Cancer Trial Database for Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

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Trial Identification

Brief Title: Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

Official Title: Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck

Study ID: NCT00017498

Conditions

Head and Neck Cancer

Interventions

gemcitabine hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck.

Detailed Description: OBJECTIVES: * Assess the therapeutic activity of gemcitabine, in terms of objective response and duration of response, in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck. * Determine the acute toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks until disease progression and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.