Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-27 @ 10:37 AM
Study NCT ID:
NCT00056459
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2003-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C404768', 'term': 'vatalanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2003-03-13', 'studyFirstSubmitQcDate': '2003-03-13', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'Throughout duration of study'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': 'Throughout duration of study'}, {'measure': 'Time to treatment failure', 'timeFrame': 'Throughout duration of study'}, {'measure': 'Best overall response rate', 'timeFrame': 'Throughout duration of study'}, {'measure': 'Tolerability and safety profile', 'timeFrame': 'Throughout duration of study'}]}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'PTK787', 'Vatalanib', 'VEGF inhibitor', 'Oxaliplatin', 'Angiogenesis', 'Rectal Cancer', 'Colon Cancer', 'Colorectal Carcinoma', 'Colorectal Tumor'], 'conditions': ['Colorectal Neoplasms', 'Colonic Neoplasms', 'Rectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21464406', 'type': 'DERIVED', 'citation': 'Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with metastatic colorectal cancer coming for initial chemotherapy\n* Documented metastatic colorectal cancer\n* WHO Performance Status of 0, 1, or 2\n* Measurable tumors\n* Adequate hematologic status, liver and kidney function\n* Life expectancy greater than 12 weeks\n* Written informed consent obtained\n\nExclusion criteria:\n\n* History or presence of central nervous system disease\n* Patients with a history of another primary cancer within 5 years\n* Prior chemotherapy for metastatic colorectal cancer\n* Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks before entry to study\n* Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study\n* Investigational drugs within 4 weeks before entry to study\n* Prior therapy with anti-VEGF agents\n* Any prior therapy with oxaliplatin or allergy to platinum-containing drugs\n* Peripheral neuropathy with functional impairment\n* Female patients who are pregnant or breast feeding\n* Any severe or uncontrolled medical conditions which could prevent participation in study\n* Patients who are taking Coumadin\n\nOther protocol-defined inclusion / exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00056459', 'briefTitle': 'Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo', 'orgStudyIdInfo': {'id': 'CPTK787 0135/306241'}, 'secondaryIdInfos': [{'id': 'CONFIRM 1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Oxaliplatin/5-FU/LV and PTK787/ZK 222584', 'interventionNames': ['Drug: Vatalanib']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Oxaliplatin/5-FU/LV and placebo', 'interventionNames': ['Drug: Vatalanib']}], 'interventions': [{'name': 'Vatalanib', 'type': 'DRUG', 'otherNames': ['PTK787/ZK 222584'], 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Hematology/Oncology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palo Verde Hematology & Oncology', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northeast Arkansas Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood and Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence St. Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care Medical Group, Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Oncology of the Central Valley', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Virginia K. 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