Clinical Trial: Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head
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 liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.
Detailed Summary:
OBJECTIVES:
- Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck.
- Determine the objective response, duration of response, and time to progression in patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of a target lesion in a previously irradiated field (within vs outside).
Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 38-72 patients (19-36 per stratum) 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: August 10, 2001
Date Started: May 2001
Date Completion:
Last Updated: July 23, 2012
Last Verified: July 2012
