Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00022594|
Recruitment Status : Completed
First Posted : June 17, 2003
Last Update Posted : July 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: liposomal lurtotecan||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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 and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||August 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022594
|Kaiser Franz Josef Hospital|
|Vienna (Wien), Austria, A-1100|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer, Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Oscar Lambret|
|Lille, France, 59020|
|CHU de la Timone|
|Marseille, France, 13385|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Paris, France, 75651|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Hamburg, Germany, D-20246|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Naples, Italy, 80131|
|Istituti Fisioterapici Ospitalieri - Roma|
|Rome, Italy, 00161|
|Antoni van Leeuwenhoekhuis|
|Amsterdam, Netherlands, 1066 CX|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa|
|Lisbon, Portugal, 1099-023 Codex|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Bern, Switzerland, CH-3010|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Study Chair:||Florence Duffaud, MD||CHU de la Timone|