Clinical trial NCT00022594: Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna (Wien)
country: Austria
facility: Kaiser Franz Josef Hospital
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille
country: France
facility: CHU de la Timone
city: Nantes-Saint Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Hamburg
country: Germany
facility: Universitats-Krankenhaus Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Naples
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri - Roma
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekhuis
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Bern
country: Switzerland
facility: Inselspital, Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: London
country: United Kingdom
facility: Royal Marsden NHS Trust
state: England
Study officials:
affiliation: CHU de la Timone
name: Florence Duffaud, MD
role: STUDY_CHAIR
References:
citation: 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.