Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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
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
Sites / Locations
- Kaiser Franz Josef Hospital
- Universitair Ziekenhuis Antwerpen
- Centre Jean Perrin
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
- Centre Oscar Lambret
- CHU de la Timone
- CRLCC Nantes - Atlantique
- CHU Pitie-Salpetriere
- Centre Henri Becquerel
- Universitats-Krankenhaus Eppendorf
- Medizinische Hochschule Hannover
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Istituti Fisioterapici Ospitalieri - Roma
- Antoni van Leeuwenhoekhuis
- University Medical Center Nijmegen
- Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
- Hospital Universitario 12 de Octubre
- Inselspital, Bern
- Centre Hospitalier Universitaire Vaudois
- Royal Marsden NHS Trust