Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 5:21 PM
Study NCT ID:
NCT00126633
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2005-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2005-08-02', 'studyFirstSubmitQcDate': '2005-08-02', 'lastUpdatePostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Duration of response'}, {'measure': 'Overall survival'}, {'measure': 'Toxicity as measured by NCI CTC version 2.0'}, {'measure': 'Micrometastases for predicting time to progression and overall survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the pancreas', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '18379729', 'type': 'RESULT', 'citation': 'Ko AH, Dito E, Schillinger B, Venook AP, Xu Z, Bergsland EK, Wong D, Scott J, Hwang J, Tempero MA. A phase II study evaluating bevacizumab in combination with fixed-dose rate gemcitabine and low-dose cisplatin for metastatic pancreatic cancer: is an anti-VEGF strategy still applicable? Invest New Drugs. 2008 Oct;26(5):463-71. doi: 10.1007/s10637-008-9127-2. Epub 2008 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and cisplatin together with bevacizumab may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with bevacizumab works in treating patients with metastatic pancreatic cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine time to disease progression in patients with previously untreated metastatic adenocarcinoma of the pancreas treated with gemcitabine, cisplatin, and bevacizumab.\n* Determine the safety and toxicity of this regimen in these patients.\n\nSecondary\n\n* Determine the objective response rate in patients treated with this regimen.\n* Determine the efficacy of this regimen, in terms of the proportion of patients with ≥ a 50% decline in the CA19-9 biomarker, in these patients.\n* Determine the median survival of patients treated with this regimen.\n* Correlate serum markers of angiogenesis and circulating tumor micrometastases with clinical outcome of patients treated with this regimen.\n\nOUTLINE: This is an open-label, non-randomized study.\n\nPatients receive gemcitabine IV over 100 minutes, cisplatin IV over 30-60 minutes, and bevacizumab\\* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional study treatment at the discretion of the investigator.\n\nNOTE: \\*Patients may continue to receive other components of therapy if bevacizumab is discontinued due to toxicity.\n\nAfter completion of study treatment, patients are followed at 28 days and then monthly thereafter.\n\nPROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the pancreas\n\n * Must have documented extrapancreatic metastases\n\n * Radiographically measurable disease is not required\n* Previously untreated disease\n* No CNS or brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa \\[Epogen®\\] support allowed)\n* No evidence of bleeding diathesis or coagulopathy\n\nHepatic\n\n* INR ≤ 1.5 (except for patients receiving full-dose warfarin)\n* Bilirubin ≤ 2.0 mg/dL\n* AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)\n\nRenal\n\n* Creatinine ≤ 2.0 mg/dL\n* Urine protein:creatinine ratio ≤ 1\n\nCardiovascular\n\n* No New York Heart Association class II-IV congestive heart failure\n* No myocardial infarction or stroke within the past 6 months\n* No uncontrolled hypertension (i.e., blood pressure \\> 160/110 mm Hg despite antihypertensive therapy)\n* No unstable angina\n* No unstable symptomatic arrhythmia requiring medication\n\n * Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible\n* No peripheral vascular disease ≥ grade 2\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after completion of study treatment\n* No significant traumatic injury within the past 28 days\n* No serious non-healing wound, ulcer, or bone fracture\n* No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No other serious systemic disease\n* No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* More than 28 days since prior major surgery, or open biopsy\n* More than 7 days since prior fine needle aspirations or core biopsies\n* No concurrent major surgery\n\nOther\n\n* No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer\n\n * Treatment given in the adjuvant setting (e.g., radiotherapy and/or chemotherapy, given either concurrently or systemically) is not considered prior therapy provided progressive disease occurred \\> 6 months after completion of prior treatment\n* Concurrent continuation of therapeutic doses of warfarin or low-molecular weight heparin allowed for pulmonary embolism, deep vein thrombosis, atrial fibrillation, or other clinical indications provided patients has been on a stable dose for ≥ 28 days with no further clotting or bleeding complications'}, 'identificationModule': {'nctId': 'NCT00126633', 'briefTitle': 'Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CDR0000437858'}, 'secondaryIdInfos': [{'id': 'UCSF-04451'}, {'id': 'GENENTECH-AVF2937s'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Andrew Ko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}