Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 7:07 AM
Study NCT ID:
NCT00008333
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2001-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV 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': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2001-01-06', 'studyFirstSubmitQcDate': '2004-02-02', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': 'Up to 5 years'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '17211864', 'type': 'BACKGROUND', 'citation': 'Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444.'}, {'pmid': '16361618', 'type': 'BACKGROUND', 'citation': 'Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.'}, {'pmid': '15165094', 'type': 'RESULT', 'citation': 'Kanard A, Jatoi A, Castillo R, Geyer S, Schulz TK, Fitch TR, Rowland KM, Nair S, Krook JE, Kugler JW. Oral vinorelbine for the treatment of metastatic non-small cell lung cancer in elderly patients: a phase II trial of efficacy and toxicity. Lung Cancer. 2004 Mar;43(3):345-53. doi: 10.1016/j.lungcan.2003.09.012.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to progression in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine whether there is a perceived preference for this oral administration in these patients. V. Determine the quality of life of these patients when treated with this drug. VI. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates in patients treated with this drug.\n\nOUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB or IV non-small cell lung cancer Measurable disease At least 1 lesion that is 2.0 cm or more in longest diameter CNS metastases allowed if previously treated and clinically stable for at least 8 weeks prior to study No meningeal carcinomatosis Participation in translational research component of this study is mandatory\n\nPATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: No dysphagia or inability to swallow capsules intact No peripheral neuropathy grade 2 or greater No other significant medical condition that would preclude study No active infection within the past 2 weeks No other malignancy within the past 5 years\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this disease within the past 5 years Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow No prior radiotherapy to measurable lesion unless documented progression after therapy No concurrent radiotherapy, including palliative radiotherapy Surgery: At least 3 weeks since prior major surgery'}, 'identificationModule': {'nctId': 'NCT00008333', 'briefTitle': 'Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy', 'orgStudyIdInfo': {'id': 'NCCTG-N0022'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02369', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'CDR0000068398', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vinorelbine', 'description': 'Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.', 'interventionNames': ['Drug: vinorelbine tartrate']}], 'interventions': [{'name': 'vinorelbine tartrate', 'type': 'DRUG', 'armGroupLabels': ['vinorelbine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5404', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Scottsdale Oncology Program', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '52403-1206', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Cedar Rapids Oncology Project', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '51101-1733', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Metro-Minnesota', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'CCOP - Missouri Valley Cancer Consortium', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'CCOP - Merit Care Hospital', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43623-3456', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Toledo Community Hospital Oncology Program', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '17822-2001', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CCOP - Geisinger Clinic and Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '57709', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Rapid City Regional Hospital', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '57104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'CCOP - Sioux Community Cancer Consortium', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Aminah Jatoi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}