Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-04 @ 11:21 AM
Study NCT ID:
NCT00087802
Status:
COMPLETED
Last Update Posted:
2009-04-16
First Post:
2004-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)
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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'C053518', 'term': 'CP protocol'}], 'ancestors': [{'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-04-15', 'studyFirstSubmitDate': '2004-07-13', 'studyFirstSubmitQcDate': '2004-07-15', 'lastUpdatePostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC', 'timeFrame': '22 months'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive\n* One (1) unidimensionally measurable lesion\n* ECOG Performance Status of 0 or 1, no peripheral neuropathy \\>Grade 1\n* Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.\n* Recovery in full from any previous surgical procedure\n* No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease\n\nExclusion Criteria:\n\n* Hypersensitivity to any of the 4 study drugs\n* Concurrent immunotherapy or participation in any investigational drug study within 4 weeks\n* Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft\n* History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)\n* Patient is a pregnant or lactating female'}, 'identificationModule': {'nctId': 'NCT00087802', 'briefTitle': 'Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'L_9210'}, 'secondaryIdInfos': [{'id': 'SR96669'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stratum 1', 'description': 'Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally', 'interventionNames': ['Drug: gemcitabine/Eloxatin (GEMOX)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stratum 2', 'description': 'Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).', 'interventionNames': ['Drug: carboplatin/paclitaxel (CP)']}], 'interventions': [{'name': 'gemcitabine/Eloxatin (GEMOX)', 'type': 'DRUG', 'description': 'GEMOX \\[gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle\\] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days \\[3-week cycle\\]', 'armGroupLabels': ['Stratum 1']}, {'name': 'carboplatin/paclitaxel (CP)', 'type': 'DRUG', 'description': 'CP \\[carboplatin/paclitaxel - 21 day cycle\\]\n\no Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days \\[3-week cycle\\]', 'armGroupLabels': ['Stratum 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Hematology and Oncology Associates, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Hematology and Oncology Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hematology Oncology Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '86336', 'city': 'Sedona', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northern Arizona Hematology & Oncology Associates', 'geoPoint': {'lat': 34.86974, 'lon': -111.76099}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona 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'country': 'United States', 'facility': 'Texas Cancer Center - Sherman', 'geoPoint': {'lat': 33.63566, 'lon': -96.60888}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Waco Cancer Care and Research Center', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Deke Slayton Cancer Center', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax Northern Virginia Hematology Oncology, PC', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 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'Yasir Nagarwala, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'sanofi-aventis'}}}}