Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 6:36 PM
Study NCT ID:
NCT00416650
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2006-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erlotinib 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': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002282', 'term': 'Adenocarcinoma, Bronchiolo-Alveolar'}], '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'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2006-12-27', 'studyFirstSubmitQcDate': '2006-12-27', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major objective response rate (complete response and partial response)', 'timeFrame': 'At 4 weeks and then every 8 weeks', 'description': 'Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \\> 30% decrease in the sum of the longest diameter (LD) of target lesions'}], 'secondaryOutcomes': [{'measure': 'Worst grade toxicity', 'timeFrame': 'weekly for 4 weeks, then every 8 weeks to discontinuation of drug', 'description': 'Number of patients with worst-grade toxicity at each of five grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death) following NCI Common Toxicity Criteria, v. 2. Drug is discontinued for disease progression, unacceptable toxicity, patient undergoes radiation or other chemotherapy, or withdraws from study'}, {'measure': 'Quality of life as measured by the Lung Cancer Symptom Scale for patients', 'timeFrame': 'baseline, every week for 5 weeks, and then every 4 weeks', 'description': 'The Lung Cancer Symptom Scale for patients is a nine-item scale with 0 = lowest rating (least) to 100 = highest rating (worst) for the measurement of symptom burden for loss of appetite, fatigue, cough, dyspnea, hemoptysis, activity, quality of life, lung cancer symptoms, and pain.'}, {'measure': 'Survival', 'timeFrame': 'from study entry to date of death or last date known alive', 'description': 'Duration of time from date of study entry to death from any cause or to the last date the patient is known to be alive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'bronchoalveolar cell lung cancer', 'recurrent non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nPURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.\n\nSecondary\n\n* Assess the quality of life of patients treated with this regimen.\n* Determine the duration of response and time to disease progression in patients treated with this regimen.\n* Determine the median survival of patients treated with this regimen.\n\nOUTLINE: This is an open-label, nonrandomized, multicenter study.\n\nPatients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)\n\n * Stage IIIB (malignant pleural or pericardial effusion) disease\n * Stage IV disease\n * Recurrent and/or medically inoperable disease\n* Measurable or evaluable indicator lesions\n* No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%\n* Life expectancy ≥ 8 weeks\n* WBC ≥ 3,000/mm³\n* Hemoglobin ≥ 9.0 g/dL\n* Platelet count ≥ 100,000/mm³\n* Bilirubin ≤ 1.0 mg/dL\n* AST ≤ 2 times upper limit of normal\n* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No significant medical history or unstable medical condition, including any of the following:\n\n * Unstable systemic disease\n * Congestive heart failure\n * Recent myocardial infarction\n * Unstable angina\n * Active infection\n * Uncontrolled hypertension\n* No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 3 weeks since prior radiation therapy to a major bone marrow-containing area\n* At least 3 weeks since prior chemotherapy\n* No more than 1 prior chemotherapy regimen for NSCLC\n* No prior systemic cytotoxic chemotherapy for other malignant diseases\n* No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \\[Herceptin®\\], or gefitinib)\n* No concurrent radiotherapy or chemotherapy'}, 'identificationModule': {'nctId': 'NCT00416650', 'briefTitle': 'Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.', 'orgStudyIdInfo': {'id': 'VCC THO 0214'}, 'secondaryIdInfos': [{'id': 'P50CA090949', 'link': 'https://reporter.nih.gov/quickSearch/P50CA090949', 'type': 'NIH'}, {'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VCC-THO-0214'}, {'id': 'VU-VCC-IRB-02-0168'}, {'id': 'GENENTECH-VU-VCC-THO-0214'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Intervention', 'description': 'Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.', 'interventionNames': ['Drug: erlotinib hydrochloride']}], 'interventions': [{'name': 'erlotinib hydrochloride', 'type': 'DRUG', 'otherNames': ['Tarceva, OSI-774'], 'description': 'All patients will receive 150 mg orally daily', 'armGroupLabels': ['Therapeutic Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'William Pao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Cancer Biology, & Pathology/ Microbiology/ Immunology; Director, Division of Hematology and Oncology; Ingram Professor of Cancer Research; Director, Personalized Cancer Medicine; Medical Oncologist', 'investigatorFullName': 'William Pao, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}