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
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | |
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 |
Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom,
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
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