Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT00150657
Status:
UNKNOWN
Last Update Posted:
2005-11-29
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-11'}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-11-28', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to progression'}], 'secondaryOutcomes': [{'measure': 'response rate'}, {'measure': 'median survival'}, {'measure': 'one year survival'}, {'measure': 'two year survival'}, {'measure': 'toxicity'}]}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '* this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added\n* the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)\n* all patients receive all three drugs; there is no placebo', 'detailedDescription': '* Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.\n* Patients with brain metastases, squamous histology, or hemoptysis are excluded.\n* All patients must give informed consent.\n* Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy\n* Stage IV disease or stage IIIB with a malignant pleural effusion\n* measurable or evaluable disease\n* Performance status 0 or 1 (ECOG)\n* adequate renal, hepatic, and bone marrow function\n* adequate recovery from previous surgery or radiotherapy\n* informed consent\n\nExclusion Criteria:\n\n* brain metastases\n* squamous (epidermoid) histology\n* hemoptysis\n* central airway disease\n* Pancoast tumors\n* previous chemotherapy or biologic therapy for lung cancer\n* prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS\n* pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT00150657', 'briefTitle': 'Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'St. John Providence Health System'}, 'officialTitle': 'Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'AVF3121s'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bevacizumab', 'type': 'DRUG'}, {'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'gemcitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael J Kraut, MD', 'role': 'CONTACT', 'email': 'mkraut@providence-hospital.org', 'phone': '248-849-8155'}, {'name': 'Howard Terebelo, DO', 'role': 'CONTACT', 'phone': '248-552-0620'}, {'name': 'Michael J Kraut, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Howard Terebelo, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anibal Drelichman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Bloom, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lyle Goldman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Judie Goodman, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Providence Cancer Institute', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}], 'centralContacts': [{'name': 'Michael J Kraut, MD', 'role': 'CONTACT', 'email': 'mkraut@providence-hospital.org', 'phone': '248-849-3541'}, {'name': 'Jaswinder Grewal, PhD', 'role': 'CONTACT', 'email': 'jgrewal@providence-hospital.org', 'phone': '248-849-5337'}], 'overallOfficials': [{'name': 'Michael J Kraut, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. John Providence Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}]}}}