Clinical Trial: Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck
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 Summary:
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.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: European Organisation for Research and Treatment of Cancer - EORTC
Dates:
Date Received: June 6, 2001
Date Started: February 2001
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012
