Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-26 @ 2:57 PM
Study NCT ID:
NCT00040768
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2002-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib in Treating Patients With 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': 'D000069286', 'term': 'Bortezomib'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'Administratively complete.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2002-07-08', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate to PS-341 therapy', 'timeFrame': 'Up to 4 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Up to 4 months', 'description': 'Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 4 hours', 'description': 'Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.'}]}, 'conditionsModule': {'conditions': ['Recurrent Non-small Cell Lung Cancer', 'Stage IIIB Non-small Cell Lung Cancer', 'Stage IV Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of bortezomib in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the response rate, time to progression, and survival of patients with advanced non-small cell lung cancer treated with bortezomib.\n\nII. Determine the toxicity of this drug in these patients. III. Correlate toxicity and activity of this drug with markers of proteasome inhibition in blood and peripheral mononuclear cells in these patients.\n\nOUTLINE:\n\nPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n\n * Mixed tumors allowed unless small cell elements are present\n* Stage IIIB or IV or recurrent disease\n* At least 1 measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan\n* No known brain metastases\n* Performance status - ECOG 0-1\n* More than 3 months\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Bilirubin ≤ 2 mg/dL\n* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement present)\n* Creatinine ≤ 2 mg/dL\n* Creatinine clearance ≥ 60 mL/min\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No peripheral neuropathy \\> grade 1\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study participation\n* No more than 1 prior chemotherapy regimen\n\n * Two prior chemotherapy regimens allowed provided 1 of the 2 regimens was gefitinib monotherapy as second-line therapy\n* At least 4 weeks since prior chemotherapy (6 weeks for carmustine, mitomycin, or nitrosoureas) and recovered\n* At least 4 weeks since prior radiotherapy (except localized radiotherapy for symptom relief) and recovered\n* Prior bortezomib allowed provided patient achieved at least a partial response (of at least 6 months duration), received no other therapy since the last dose of bortezomib, and has no residual toxicity greater than grade 1\n* No other concurrent investigational or commercial agents or therapies for malignancy'}, 'identificationModule': {'nctId': 'NCT00040768', 'briefTitle': 'Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-02470'}, 'secondaryIdInfos': [{'id': 'UPCC 06501'}, {'id': 'CDR0000069405', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (bortezomib)', 'description': 'Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.', 'interventionNames': ['Drug: bortezomib']}], 'interventions': [{'name': 'bortezomib', 'type': 'DRUG', 'otherNames': ['LDP 341', 'MLN341', 'VELCADE'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (bortezomib)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of The University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'James Stevenson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}