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

July 23, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna (Wien), Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Marseille, France, 13385
        • CHU de la Timone
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Germany
      • Hamburg, Germany, D-20246
        • Universitats-Krankenhaus Eppendorf
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
  • Italy
      • Naples, Italy, 80131
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
      • Rome, Italy, 00161
        • Istituti Fisioterapici Ospitalieri - Roma
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
  • Portugal
      • Lisbon, Portugal, 1099-023 Codex
        • Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck

    • Metastatic or loco-regionally recurrent disease
  • No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas
  • No tumors of the nasal or paranasal cavities or of the nasopharynx
  • Measurable disease
  • No clinical symptomatic evidence of brain or leptomeningeal metastases
  • Ineligible for loco-regional treatment after chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.5 times ULN
  • No uncontrolled hypercalcemia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after study
  • No known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug
  • No uncontrolled systemic disease or infection
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • No other prior or concurrent malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent anticancer biological therapy or immune response modifiers
  • No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy for recurrent disease
  • No prior therapy with camptothecin analogues
  • At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy
  • No other concurrent anticancer cytotoxic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • At least 30 days since prior experimental drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Florence Duffaud, MD, CHU de la Timone

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

June 16, 2003

First Posted (Estimate)

June 17, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16008
  • GILEAD-110-10
  • OSI-EORTC-16008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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