Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00005093
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2000-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine With or Without CI-994 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'}], '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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C081895', 'term': 'tacedinaline'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2001-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-08', 'studyFirstSubmitDate': '2000-04-06', 'studyFirstSubmitQcDate': '2004-06-17', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the efficacy and safety of gemcitabine with or without CI-994 in patients with advanced non-small cell lung cancer.\n\nOUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to performance status and are randomized to one of two treatment arms. Arm I: Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Arm II: Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I. Treatment repeats every 28 days as long as medically appropriate (absence of disease progression or unacceptable toxicity).\n\nPROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent, locally advanced, or metastatic, unresectable non-small cell lung cancer Failed or relapsed after one prior platinum containing regimen (cisplatin or carboplatin) as first line therapy Prior brain metastases allowed if resection and/or radiotherapy completed, no worsening of CNS symptoms, and at least 1 month since prior corticosteroids\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN in patients with liver metastases) Renal: Creatinine clearance at least 50 mL/min Other: Able to swallow intact study capsules No active infection No life threatening illness (other than tumor) No prior malignancy within the past 5 years except well controlled nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No more than one prior regimen of chemotherapy No prior gemcitabine No prior CI-994 At least 4 weeks since prior maintenance or consolidation therapy (e.g., matrix metalloprotein inhibitors) Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to primary site Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00005093', 'briefTitle': 'Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'PD-994-013'}, 'secondaryIdInfos': [{'id': 'CDR0000067735'}, {'id': 'ILEX-994-013'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'tacedinaline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Medical Center Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-0752', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Hematology/Oncology Associates - Wake Practice', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital - Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38117', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Clinic, P.C.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Regional Cancer Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Fraser Valley Cancer Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 1J8', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Island Cancer Centre', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Center - General Division', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital - Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kathryn Kimmel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pfizer Incorporated - Ann Arbor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}