Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 7:31 AM
Study NCT ID:
NCT00673504
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077210', 'term': 'Sunitinib'}], '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': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': 'once all patients completed treatment'}], 'secondaryOutcomes': [{'measure': 'Response Rate (RR)', 'timeFrame': 'once all patients completed treatment'}, {'measure': 'overall survival', 'timeFrame': 'at study end'}, {'measure': 'Safety', 'timeFrame': 'at study end'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'pancreatic cancer', 'gemcitabine', 'sunitinib', 'Phase 2'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cesar.or.at/main.asp?VID=1&kat1=49&kat2=370&kat3=&Text=&SSSID=5', 'label': "German Study Description on CESAR's homepage"}]}, 'descriptionModule': {'briefSummary': 'Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who suffer from locally advanced or metastatic pancreatic cancer\n* Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).\n* ECOG performance status 0 to 1\n* Signed written informed consent.\n* White blood cell count (WBC) \\>= 3x10\\^9/L with neutrophils \\>= 1.5 x 10\\^9/L, platelet count \\>= 100x10\\^9/L, hemoglobin \\>= 5.6 mmol/L (9 g/dL).\n* Total bilirubin \\< 2 x upper limit of normal.\n* AST and ALT \\< 2.5 x upper limit of normal, or \\< 5 x upper limit of normal in case of liver metastases.\n* Serum creatinine \\< 1.5 x upper limit of normal\n* Normal ECG without QT prolongation\n\nExclusion Criteria:\n\n* Resectable pancreatic cancer\n* Previous chemotherapy (for adjuvant or metastatic disease)\n* Any investigational drug within the 30 days before inclusion.\n* Prior use of sunitinib or other multitarget tyrosine kinase inhibitor\n* Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.\n* Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.\n* Clinically symptomatic brain or meningeal metastasis. (known or suspected)\n* Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).\n* History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) \\> NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism\n* Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs\n* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea\n* Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \\[Ta, Tis and T1\\].\n* History of organ allograft\n* Patients requiring long-term cortisone therapy\n* Patients requiring oral anticoagulation treatment (such as marcoumar)'}, 'identificationModule': {'nctId': 'NCT00673504', 'briefTitle': 'First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Central European Society for Anticancer Drug Research'}, 'officialTitle': 'Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'C-II-004 / 2007-005022-71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Gemcitabine + Sunitinib', 'interventionNames': ['Drug: Gemcitabine + Sunitinib']}, {'type': 'OTHER', 'label': 'B', 'description': 'Gemcitabine', 'interventionNames': ['Drug: Gemcitabine']}], 'interventions': [{'name': 'Gemcitabine + Sunitinib', 'type': 'DRUG', 'description': 'Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)', 'armGroupLabels': ['A']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': '1.000 mg/m2 d1,8,15q4weeks', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38114', 'city': 'Braunschweig', 'country': 'Germany', 'facility': 'Städtisches Klinikum Braunschweig', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60488', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Krankenhaus', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Internistisches Facharztzentrum', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '06097', 'city': 'Halle', 'country': 'Germany', 'facility': 'Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Facharztpraxis', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '58515', 'city': 'Lüdenscheid', 'country': 'Germany', 'facility': 'Klinikum Lüdenscheid', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Nord', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central European Society for Anticancer Drug Research', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Central European Society for Anticancer Drug Research-EWIV', 'oldOrganization': 'Non-Profit Otrganization Oncology'}}}}