Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
NCT ID: NCT00022594
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2001-05-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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liposomal lurtotecan
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Florence Duffaud, MD
Role: STUDY_CHAIR
CHU de la Timone
Locations
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Kaiser Franz Josef Hospital
Vienna (Wien), , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
CHU de la Timone
Marseille, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
CHU Pitie-Salpetriere
Paris, , France
Centre Henri Becquerel
Rouen, , France
Universitats-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , Italy
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
Lisbon, , Portugal
Hospital Universitario 12 de Octubre
Madrid, , Spain
Inselspital, Bern
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Royal Marsden NHS Trust
London, England, United Kingdom
Countries
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References
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Duffaud F, Borner M, Chollet P, Vermorken JB, Bloch J, Degardin M, Rolland F, Dittrich C, Baron B, Lacombe D, Fumoleau P; EORTC-New Drug Development Group/New Drug Development Program. Phase II study of OSI-211 (liposomal lurtotecan) in patients with metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC New Drug Development Group study. Eur J Cancer. 2004 Dec;40(18):2748-52. doi: 10.1016/j.ejca.2004.08.024.
Other Identifiers
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EORTC-16008
Identifier Type: -
Identifier Source: secondary_id
GILEAD-110-10
Identifier Type: -
Identifier Source: secondary_id
OSI-EORTC-16008
Identifier Type: -
Identifier Source: secondary_id
EORTC-16008
Identifier Type: -
Identifier Source: org_study_id