Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-28 @ 10:42 AM
Study NCT ID:
NCT00045604
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2002-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-04', 'lastUpdateSubmitDate': '2008-07-23', 'studyFirstSubmitDate': '2002-09-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['extensive stage small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of imatinib mesylate when administered with irinotecan and cisplatin in patients with extensive stage small cell lung cancer.\n* Determine the effect of imatinib mesylate on irinotecan metabolism by the cytochrome p450 system in these patients.\n* Determine the response rate, time to progression, and survival of patients treated with this regimen.\n\nOUTLINE: This is a dose-escalation study of imatinib mesylate.\n\nPatients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral imatinib mesylate once or twice daily beginning on day 22 of course 1 and continuing until disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed small cell lung cancer\n\n * Extensive stage disease\n* Measurable or evaluable indicator lesion\n* No symptomatic or uncontrolled brain or leptomeningeal involvement\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 4,000/mm3\n* Platelet count at least 160,000/mm3\n* Hemoglobin at least 10 g/dL\n\nHepatic\n\n* Bilirubin no greater than 1 mg/dL\n* AST no greater than 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 5 times ULN\n\nRenal\n\n* Creatinine less than 1.5 mg/dL OR\n* Creatinine clearance at least 50 mL/min\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No uncontrolled cardiac arrhythmia\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception during and for 3 months after study\n* No other active cancer except previously treated carcinoma in situ, non -melanoma skin cancer, or stage I prostate cancer\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study\n* No other concurrent uncontrolled illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate for rheumatoid arthritis)\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 2 weeks since prior radiotherapy to major bone marrow-containing areas\n\nSurgery\n\n* Not specified\n\nOther\n\n* No concurrent warfarin for therapeutic anticoagulation\n\n * Low-molecular weight heparin or heparin allowed'}, 'identificationModule': {'nctId': 'NCT00045604', 'briefTitle': 'Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CDR0000256923'}, 'secondaryIdInfos': [{'id': 'MSKCC-02015'}, {'id': 'NCI-5653'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'imatinib mesylate', 'type': 'DRUG'}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Lee M. Krug, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}