Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck|
|Study Start Date:||February 2001|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
- 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.
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Ospedale Santa Croce|
|Cuneo, Italy, 12100|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Milan, Italy, 20133|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1007 MB|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Study Chair:||Pieter H. M. de Mulder, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|