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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Ospedale Santa Croce, Cuneo, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, , Italy
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Name: Pieter H. M. de Mulder, MD, PhD
Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen
Role: STUDY_CHAIR