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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

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Pieter H. M. de Mulder, MD, PhD

Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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