Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00022594
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 Description

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.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2001-08-10
• Primary Completion: 2002-08
• Study First Submitted QC: 2003-06-16
• Study First Posted: 2003-06-17
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Istituto Nazionale per lo Studio e la Cura dei Tumori; 🇮🇹 Naples, Italy

CHU de la Timone; 🇫🇷 Marseille, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Centre Oscar Lambret; 🇫🇷 Lille, France

Kaiser Franz Josef Hospital; 🇦🇹 Vienna (Wien), Austria

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitats-Krankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa; 🇵🇹 Lisbon, Portugal

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Istituti Fisioterapici Ospitalieri - Roma; 🇮🇹 Rome, Italy