Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00088556
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2004-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell 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': 'C107479', 'term': 'TER 286'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-30', 'studyFirstSubmitDate': '2004-07-29', 'studyFirstSubmitQcDate': '2004-07-29', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Objectives', 'timeFrame': 'Every 6 Weeks', 'description': '1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin\n2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin\n3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin'}]}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Histologically confirmed non-small cell lung cancer (NSCLC)\n* Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)\n* Measurable disease by RECIST\n* ECOG status of 0-1\n* Adequate liver and renal function\n* Adequate bone marrow reserves\n\nExclusion Criteria:\n\n* Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC\n* Up to one prior adjuvant or neoadjuvant chemotherapy is allowed\n* History of bone marrow transplantation or stem cell support\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00088556', 'briefTitle': 'Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Telik'}, 'officialTitle': 'Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'TLK286.2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triplet Combination of TLK286 Carboplatin & Paclitaxel', 'description': 'Experimental', 'interventionNames': ['Drug: TLK286', 'Drug: carboplatin', 'Drug: paclitaxel']}], 'interventions': [{'name': 'TLK286', 'type': 'DRUG', 'description': 'Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²', 'armGroupLabels': ['Triplet Combination of TLK286 Carboplatin & Paclitaxel']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'AUC 6 mg/mL/min Once every 3 weeks', 'armGroupLabels': ['Triplet Combination of TLK286 Carboplatin & Paclitaxel']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': '200 mg/m² Once every 3 weeks', 'armGroupLabels': ['Triplet Combination of TLK286 Carboplatin & Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Medical Oncology/Hematology Associates', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Cancer Care', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 37.66882, 'lon': -122.0808}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Cancer Care', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Cancer Care', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '94080', 'city': 'So. San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center'}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '94520', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Valley Oncology & Hematology Medical Group', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '34429', 'city': 'Crystal River', 'state': 'Florida', 'country': 'United States', 'facility': 'Citrus Hematology and Oncology', 'geoPoint': {'lat': 28.90248, 'lon': -82.5926}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Citrus Hematology and Oncology Center', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Wellcare Alliance, LC', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '66112', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Department of Veterns Affairs - Overton Brooks VA Medical Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders, P. C.', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64064', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Hospital", 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '69361', 'city': 'Scottsbluff', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Clinical Research Service', 'geoPoint': {'lat': 41.86663, 'lon': -103.66717}}, {'zip': '69361', 'city': 'Scottsbluff', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Horizons West Medical Group', 'geoPoint': {'lat': 41.86663, 'lon': -103.66717}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Dakota Cancer Institute', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Odyssey Research', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '37043', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37076', 'city': 'Hermitage', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.19617, 'lon': -86.6225}}, {'zip': '37087', 'city': 'Lebanon', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.20811, 'lon': -86.2911}}, {'zip': '37130', 'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37207', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Associates', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Danville Hematology & Oncology, Inc.', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telik', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}