Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT00064012
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2003-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2003-07-08', 'studyFirstSubmitQcDate': '2003-07-08', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'recurrent non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '17075122', 'type': 'RESULT', 'citation': 'Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers HJ, Axelrod R, Kashala O, Sheng S, Schiller JH. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025-33. doi: 10.1200/JCO.2006.06.1853.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel.\n\nSecondary\n\n* Compare time to progression in patients treated with these regimens.\n* Compare the overall and 1-year survival of patients treated with these regimens.\n* Compare the safety and tolerability of these regimens in these patients.\n* Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.\n* Compare the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.\n* Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I.\n\nIn both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR.\n\nQuality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment.\n\nPatients are followed at 30 days and then every 3 months for survival.\n\nPROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n\n * Locally advanced (stage IIIB) or metastatic (stage IV) disease\n * Inoperable disease\n* Relapsed or refractory disease\n\n * Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease\n* Measurable or evaluable disease\n* No symptomatic or inadequately treated brain metastases\n* No CNS disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 8.0 g/dL\n* Absolute neutrophil count greater than 1,500/mm\\^3\n\nHepatic\n\n* AST and ALT less than 3 times upper limit of normal (ULN)\n* Bilirubin less than 1.5 times ULN\n* Hepatitis B surface antigen negative\n* Hepatitis C negative\n\nRenal\n\n* Creatinine less than 1.8 mg/dL\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n* No New York Heart Association class III or IV heart failure\n* No uncontrolled angina\n* No severe uncontrolled ventricular arrhythmias\n* No electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n* No poorly controlled hypertension\n\nImmunologic\n\n* No active systemic infection requiring treatment\n* No prior allergic reaction attributable to compounds containing boron or mannitol\n* HIV negative\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n* No peripheral neuropathy grade 2 or greater\n* No diabetes mellitus\n* No other serious medical or psychiatric condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 6 weeks since prior monoclonal antibody therapy\n* No concurrent routine use of colony-stimulating factors (e.g., filgrastim \\[G-CSF\\] or sargramostim \\[GM-CSF\\])\n* No concurrent immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior chemotherapy\n* No prior docetaxel\n\n * Prior paclitaxel allowed\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* More than 4 weeks since prior major surgery\n* No concurrent surgery for cancer management or treatment\n\nOther\n\n* More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix\n* More than 4 weeks since prior investigational agents\n* No prior bortezomib\n* No other concurrent investigational agents\n* No other concurrent clinical research study participation\n* No other concurrent antineoplastic therapy\n* No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)'}, 'identificationModule': {'nctId': 'NCT00064012', 'briefTitle': 'Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CDR0000305974'}, 'secondaryIdInfos': [{'id': 'P30CA016042', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016042', 'type': 'NIH'}, {'id': 'WCCC-M34102-048'}, {'id': 'UCLA-0301037'}, {'id': 'MILLENNIUM-M34102-048'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Velcade Alone', 'description': 'Velcade', 'interventionNames': ['Drug: bortezomib']}, {'type': 'EXPERIMENTAL', 'label': 'Velcade plus Docetaxel', 'description': 'Velcade plus Docetaxel', 'interventionNames': ['Drug: bortezomib', 'Drug: docetaxel']}], 'interventions': [{'name': 'bortezomib', 'type': 'DRUG', 'armGroupLabels': ['Velcade Alone', 'Velcade plus Docetaxel']}, {'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['Velcade plus Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-2115', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center at University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520-8028', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Comprehensive Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Atlanta (Decatur)', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hubert H. Humphrey Cancer Center at North Memorial Medical Center', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Centers - Central', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University Hospital Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28232-2861', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blumenthal Cancer Center at Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Kimmel Cancer Center at Thomas Jefferson University - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232-6868', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792-5666', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Joan H. Schiller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}