Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-09 @ 4:04 PM
Study NCT ID:
NCT00642733
Status:
TERMINATED
Last Update Posted:
2016-08-24
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival; time to progression', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Duration of response; disease-free survival', 'timeFrame': 'Event driven'}, {'measure': 'AEs, lab parameters', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* pancreatic cancer, surgically unresectable or with metastases;\n* no previous chemotherapy (except concomitant with radiotherapy);\n* ECOG 0-2.\n\nExclusion Criteria:\n\n* pancreatic cancer without histologic or cytologic confirmation;\n* surgical resection possible;\n* previous chemotherapy not concomitant with radiotherapy;\n* ECOG 3-4.'}, 'identificationModule': {'nctId': 'NCT00642733', 'briefTitle': 'A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'ML21285'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: erlotinib [Tarceva]', 'Drug: gemcitabine']}], 'interventions': [{'name': 'erlotinib [Tarceva]', 'type': 'DRUG', 'description': '100mg po daily', 'armGroupLabels': ['1']}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': '1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58070', 'city': 'Morelia', 'country': 'Mexico', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'zip': '22320', 'city': 'Tijuana', 'country': 'Mexico', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}