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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00022594
First received: August 10, 2001
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: liposomal lurtotecan
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 50
Study Start Date: May 2001
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022594

Locations
Austria
Kaiser Franz Josef Hospital
Vienna (Wien), Austria, A-1100
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
France
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
CHU Pitie-Salpetriere
Paris, France, 75651
Centre Henri Becquerel
Rouen, France, 76038
Germany
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Portugal
Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
Lisbon, Portugal, 1099-023 Codex
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
Inselspital, Bern
Bern, Switzerland, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Florence Duffaud, MD CHU de la Timone
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00022594     History of Changes
Other Study ID Numbers: EORTC-16008, EORTC-16008, GILEAD-110-10, OSI-EORTC-16008
Study First Received: August 10, 2001
Last Updated: July 23, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Lurtotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014