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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022594
• Other study ID #: EORTC-16008
• Secondary ID: EORTC-16008GILEA
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: July 23, 2012
• Start date: May 2001

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• liposomal lurtotecan

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna (Wien)
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
France	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
Germany	Universitats-Krankenhaus Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	University Medical Center Nijmegen	Nijmegen
Portugal	Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa	Lisbon
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Inselspital, Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Royal Marsden NHS Trust	London	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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 meta — View Citation