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	Treatment or Intervention	Phase
Neck Cancer Oral Cancer Throat Cancer	Procedure: chemotherapy  Drug: lurtotecan liposome	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck. II. Determine the objective response, duration of response, and time to progression in patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--Patient Characteristics--

Age: 18 and over

Performance status: ECOG 0-2

Life expectancy: Not specified

Hematopoietic:

• Neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3

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

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

Study chairs or principal investigators

Florence Duffaud,  Study Chair,  European Organization for Research and Treatment of Cancer   

Study ID Numbers:  CDR0000068833; EORTC-16008; GILEAD-110-10; OSI-EORTC-16008
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022594
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08