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

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

Sponsoren

Hauptsponsor: European Organisation for Research and Treatment of Cancer - EORTC

Quelle European Organisation for Research and Treatment of Cancer - EORTC
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum May 2001
Primäres Abschlussdatum August 2002
Phase Phase 2
Studientyp Interventional
Einschreibung 50
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: liposomal lurtotecan

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

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

Austria

Belgium

France

Germany

Italy

Netherlands

Portugal

Spain

Switzerland

United Kingdom

Überprüfungsdatum

July 2012

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov