Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT00821912
Status:
UNKNOWN
Last Update Posted:
2012-02-28
First Post:
2009-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TaxXel: Taxotere and Xeloda in Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-27', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'description': 'Response rate will be defined as the percentage of patients who achieve a complete response (CR) or partial response (PR).\n\nDuration of a CR or PR will be calculated from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.'}], 'secondaryOutcomes': [{'measure': 'CT scan', 'timeFrame': 'Every 9 weeks'}, {'measure': 'Toxicity assessment', 'timeFrame': 'Every three weeks'}, {'measure': 'Quality of life', 'timeFrame': 'Every three weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer of the Esophagus', 'Gastric Cardia Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase.\n\nThe primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia.\n* Inoperable metastatic disease\n* Performance status (WHO) of 0-2\n* Measurable disease.\n* Adequate hematological, liver and renal function.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* CNS metastases\n* Symptomatic peripheral neuropathy equal to or greater than NCI grade 2.\n* Other concomitant serious illness or medical condition.\n* Past or current history of malignant neoplasm other than oesophageal carcinoma.\n* \\<18 years of age. Pregnant or lactating patients.'}, 'identificationModule': {'nctId': 'NCT00821912', 'acronym': 'TaxXel', 'briefTitle': 'TaxXel: Taxotere and Xeloda in Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region', 'orgStudyIdInfo': {'id': 'TaxXel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taxotere Xeloda', 'description': 'Taxotere i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule.\n\nXeloda orally day 1-14 every 3 weeks.', 'interventionNames': ['Drug: Docetaxel', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': '30 mg/m2, administered as a 30 min. i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule', 'armGroupLabels': ['Taxotere Xeloda']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': '1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.', 'armGroupLabels': ['Taxotere Xeloda']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland universitetssykehus', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '0310', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo universitetssykehus, Radiumhospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo universitetssykehus, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Malmö General University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Dept of Oncology', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '851 86', 'city': 'Sundsvall', 'country': 'Sweden', 'facility': 'Sundsvall County Hospital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala Akademic Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '721 89', 'city': 'Västerås', 'country': 'Sweden', 'facility': 'Västerås Central Hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Signe Friesland, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Signe Friesland', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}