Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-29 @ 3:46 AM
Study NCT ID:
NCT00005850
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005473', 'term': 'Fluoxetine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the MHI-17 global psychological distress subscale', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 2 years post-treatment'}, {'measure': 'Failure-free survival', 'timeFrame': 'Up to 2 years post-treatment'}]}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'recurrent non-small cell lung cancer', 'squamous cell lung cancer', 'large cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'adenocarcinoma of the lung', 'adenosquamous cell lung cancer', 'fatigue', 'anxiety disorder', 'depression'], 'conditions': ['Anxiety Disorder', 'Depression', 'Fatigue', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': "This trial is designed to test the efficacy of fluoxetine to improve patient's quality of life during chemotherapy. An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of life.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary Objectives:\n\n1. To preliminarily test the efficacy of fluoxetine to improve the quality of life of patients with advanced non-small cell lung cancer receiving chemotherapy by decreasing anxiety, depression and fatigue.\n2. To test the feasibility of conducting a multi-center clinical trial of fluoxetine administered by oncologists concurrently with chemotherapy in patients with non-small cell lung cancer.\n\nSecondary Objectives:\n\n1. To describe the tumor response rate associated with the administration of gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.\n2. To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.\n3. To describe the toxicity associated with the administration of gemcitabine/cisplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Eligibility Criteria:\n\n1. Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types).\n2. Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy.\n\n * Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible.\n * Patients with known CNS metastases are not eligible.\n3. Measurable or Non-Measurable Disease\n\n * Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.\n * Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter \\< 20 mm with conventional techniques or \\< 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible.\n\n Lesions that are considered non-measurable include the following:\n * Bone lesions\n * Leptomeningeal disease\n * Ascites\n * Pleural/pericardial effusion\n * Abdominal masses that are not confirmed and followed by imaging techniques\n * Cystic lesions\n4. Prior Treatment:\n\n * No prior chemotherapy.\n * ≥ 2 weeks since radiation therapy.\n * No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month.\n5. If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone.\n6. CTC Performance Status 0-1.\n7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.\n8. Required Initial Laboratory Data:\n\n * Granulocytes ≥ 1,500/µl\n * Platelet count ≥ 100,000/µl\n * Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min\n * Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN)\n * Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN"}, 'identificationModule': {'nctId': 'NCT00005850', 'briefTitle': 'Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy', 'orgStudyIdInfo': {'id': 'CALGB-119802'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CLB-119802'}, {'id': 'CDR0000067871', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gemcitabine + cisplatin + fluoxetine', 'description': 'Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.', 'interventionNames': ['Drug: cisplatin', 'Drug: fluoxetine', 'Drug: gemcitabine hydrochloride']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'description': '80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.', 'armGroupLabels': ['gemcitabine + cisplatin + fluoxetine']}, {'name': 'fluoxetine', 'type': 'DRUG', 'description': '10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.', 'armGroupLabels': ['gemcitabine + cisplatin + fluoxetine']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': '1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.', 'armGroupLabels': ['gemcitabine + cisplatin + fluoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northeast Alabama Regional Medical Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Washington, DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward General Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital Comprehensive Cancer Center', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Louis A. Weiss Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60305', 'city': 'River Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'West Suburban Center for Cancer Care', 'geoPoint': {'lat': 41.89781, 'lon': -87.81395}}, {'zip': '61108', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Saint Anthony Medical Center', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '46885-5099', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology and Hematology, Incorporated', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Hospital East - Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'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': 'Beth Israel Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland Medical Center - St. Joseph', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '11373', 'city': 'Elmhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Elmhurst Hospital Center', 'geoPoint': {'lat': 40.73649, 'lon': -73.87791}}, {'zip': '11432', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Queens Cancer Center of Queens Hospital', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'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': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York - Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13217', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28805', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Asheville', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NorthEast Oncology Associates', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28302-2000', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cape Fear Valley Health System', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '28503-1678', 'city': 'Kinston', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lenoir Memorial Hospital Cancer Center', 'geoPoint': {'lat': 35.26266, 'lon': -77.58164}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth Moore Regional Hospital', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '28402-9025', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'New Hanover Regional Medical Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '58102', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Fargo', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22901', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Martha Jefferson Hospital', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates - Norfolk', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oncology and Hematology Associates of Southwest Virginia, Inc.', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': "St. Mary's Medical Center", 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'zip': '54501', 'city': 'Rhinelander', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ministry Medical Group - Northern Region', 'geoPoint': {'lat': 45.63662, 'lon': -89.41208}}, {'zip': '00936-5067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico School of Medicine Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Donna Greenberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}