Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 4:08 AM
Study NCT ID:
NCT00022594
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2001-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-23', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-06-16', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '15571957', 'type': 'RESULT', 'citation': '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 metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC New Drug Development Group study. Eur J Cancer. 2004 Dec;40(18):2748-52. doi: 10.1016/j.ejca.2004.08.024.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck.\n* Determine the objective response, duration of response, and time to progression in patients treated with this drug.\n* Determine the toxicity profile of this drug in these patients.\n* Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in these patients.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to presence of a target lesion in a previously irradiated field (within vs outside).\n\nPatients 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.\n\nPatients are followed every 6 weeks.\n\nPROJECTED ACCRUAL: A total of 38-72 patients (19-36 per stratum) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous cell carcinoma of the head and neck\n\n * Metastatic or loco-regionally recurrent disease\n* No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas\n* No tumors of the nasal or paranasal cavities or of the nasopharynx\n* Measurable disease\n* No clinical symptomatic evidence of brain or leptomeningeal metastases\n* Ineligible for loco-regional treatment after chemotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n* No uncontrolled hypercalcemia\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 30 days after study\n* No known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug\n* No uncontrolled systemic disease or infection\n* No psychological, familial, sociological, or geographical condition that would preclude study\n* 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\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent anticancer biological therapy or immune response modifiers\n* No concurrent prophylactic hematopoietic growth factors\n\nChemotherapy:\n\n* See Disease Characteristics\n* No prior chemotherapy for recurrent disease\n* No prior therapy with camptothecin analogues\n* At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy\n* No other concurrent anticancer cytotoxic therapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 8 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 30 days since prior experimental drug'}, 'identificationModule': {'nctId': 'NCT00022594', 'briefTitle': 'Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EORTC-16008'}, 'secondaryIdInfos': [{'id': 'EORTC-16008'}, {'id': 'GILEAD-110-10'}, {'id': 'OSI-EORTC-16008'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'liposomal lurtotecan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1100', 'city': 'Vienna (Wien)', 'country': 'Austria', 'facility': 'Kaiser Franz Josef Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer, Georges-Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44805', 'city': 'Nantes-Saint Herblain', 'country': 'France', 'facility': 'CRLCC Nantes - Atlantique'}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': 'D-20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitats-Krankenhaus Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'D-30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Istituto Nazionale per lo Studio e la Cura dei Tumori', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Istituti Fisioterapici Ospitalieri - Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Antoni van Leeuwenhoekhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '1099-023 Codex', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Florence Duffaud, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de la Timone'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}