Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-31 @ 5:11 AM
Study NCT ID:
NCT00103103
Status:
TERMINATED
Last Update Posted:
2010-10-13
First Post:
2005-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-11', 'studyFirstSubmitDate': '2005-02-07', 'studyFirstSubmitQcDate': '2005-02-07', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate as measured by RECIST every 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to progression every 8 weeks'}, {'measure': 'Overall survival'}, {'measure': 'Toxicity every 4 weeks'}, {'measure': 'Molecular correlates on and off study treatment'}]}, 'conditionsModule': {'keywords': ['recurrent gastric cancer', 'stage IV gastric cancer', 'adenocarcinoma of the stomach'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib, fluorouracil, and leucovorin calcium.\n\nSecondary\n\n* Determine time to progression and overall survival of patients treated with this regimen.\n* Determine the toxic effects of this regimen in these patients.\n\nOUTLINE: This is a non-randomized, multicenter study.\n\nPatients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of gastric or gastroesophageal junction adenocarcinoma\n\n * Metastatic or unresectable disease\n* Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following:\n\n * Fluorouracil\n * Cisplatin and irinotecan\n * Capecitabine\n * Taxanes\n* Measurable disease\n* No esophageal cancer\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-2 OR\n* Karnofsky 60-100%\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin normal\n* AST and ALT ≤ 2.5 times upper limit of normal\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No acute ischemia by EKG\n* No significant conduction abnormality by EKG, including either of the following:\n\n * Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block\n * Second or third degree atrioventricular block\n* No history of cardiac or cerebrovascular disease due to hypotension and tachycardia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception before, during, and for 6 months after study participation\n* No ongoing or active infection\n* No other uncontrolled illness\n* No peripheral neuropathy ≥ grade 2 within the past 2 weeks\n* No allergy to boron or mannitol\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 4 weeks since prior immunotherapy\n\nChemotherapy\n\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* More than 2 weeks since prior major surgery\n\nOther\n\n* No concurrent highly active anti-retroviral therapy for HIV-positive patients\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00103103', 'briefTitle': 'Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'California Cancer Consortium'}, 'officialTitle': 'A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CDR0000410827'}, 'secondaryIdInfos': [{'id': 'CCC-PHII-43'}, {'id': 'NCI-5991'}, {'id': 'LAC-USC-3G036'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bortezomib', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Group', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hillman Cancer Center at University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Heinz-Josef Lenz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Cancer Consortium', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}