Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
- Conditions
- Head and Neck Cancer
- Registration Number
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Ospedale Santa Croce
🇮🇹Cuneo, Italy
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Institut Jules Bordet
🇧🇪Brussels, Belgium
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Milan, Italy