--- title: Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer nct_id: NCT00022594 overall_status: COMPLETED phase: PHASE2 sponsor: European Organisation for Research and Treatment of Cancer - EORTC study_type: INTERVENTIONAL primary_condition: Head and Neck Cancer countries: Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00022594.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00022594" ct_last_update_post_date: 2012-07-24 last_seen_at: "2026-05-12T07:08:07.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer **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 **NCT ID:** [NCT00022594](https://clinicaltrials.gov/study/NCT00022594) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 50 - **Lead Sponsor:** European Organisation for Research and Treatment of Cancer - EORTC - **Conditions:** Head and Neck Cancer - **Start Date:** 2001-05 - **CT.gov Last Update:** 2012-07-24 ## Brief 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. ## Detailed 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Interventions - **liposomal lurtotecan** (DRUG) ## Locations (20) - Kaiser Franz Josef Hospital, Vienna (Wien), Austria - Universitair Ziekenhuis Antwerpen, Edegem, Belgium - 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, France - Universitats-Krankenhaus Eppendorf, Hamburg, Germany - Medizinische Hochschule Hannover, Hanover, Germany - Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, Italy - Istituti Fisioterapici Ospitalieri - Roma, Rome, Italy - Antoni van Leeuwenhoekhuis, Amsterdam, Netherlands - University Medical Center Nijmegen, Nijmegen, Netherlands - Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa, Lisbon, Portugal - Hospital Universitario 12 de Octubre, Madrid, Spain - Inselspital, Bern, Bern, Switzerland - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland - Royal Marsden NHS Trust, London, England, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.kaiser franz josef hospital|vienna (wien)||austria` — added _(2026-05-12)_ - `locations.universitair ziekenhuis antwerpen|edegem||belgium` — added _(2026-05-12)_ - `locations.centre jean perrin|clermont-ferrand||france` — added _(2026-05-12)_ - `locations.centre de lutte contre le cancer, georges-francois leclerc|dijon||france` — added _(2026-05-12)_ - `locations.centre oscar lambret|lille||france` — added _(2026-05-12)_ - `locations.chu de la timone|marseille||france` — added _(2026-05-12)_ - `locations.crlcc nantes - atlantique|nantes-saint herblain||france` — added _(2026-05-12)_ - `locations.chu pitie-salpetriere|paris||france` — added _(2026-05-12)_ - `locations.centre henri becquerel|rouen||france` — added _(2026-05-12)_ - `locations.universitats-krankenhaus eppendorf|hamburg||germany` — added _(2026-05-12)_ - `locations.medizinische hochschule hannover|hanover||germany` — added _(2026-05-12)_ - `locations.istituto nazionale per lo studio e la cura dei tumori|naples||italy` — added _(2026-05-12)_ - `locations.istituti fisioterapici ospitalieri - roma|rome||italy` — added _(2026-05-12)_ - `locations.antoni van leeuwenhoekhuis|amsterdam||netherlands` — added _(2026-05-12)_ - `locations.university medical center nijmegen|nijmegen||netherlands` — added _(2026-05-12)_ - `locations.instituto portugues de oncologia de francisco gentil-centro de lisboa|lisbon||portugal` — added _(2026-05-12)_ - `locations.hospital universitario 12 de octubre|madrid||spain` — added _(2026-05-12)_ - `locations.inselspital, bern|bern||switzerland` — added _(2026-05-12)_ - `locations.centre hospitalier universitaire vaudois|lausanne||switzerland` — added _(2026-05-12)_ - `locations.royal marsden nhs trust|london|england|united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00022594.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00022594* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*