Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT00052494
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy and Imatinib Mesylate 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'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': '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': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2003-01-24', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['extensive stage small cell lung cancer', 'recurrent small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and imatinib mesylate 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 cisplatin and irinotecan in patients with extensive stage small cell lung cancer.\n* Determine the recommended phase II dose of imatinib mesylate in patients treated with this regimen.\n* Determine the response rate, median duration of response, progression-free survival, median survival, and overall survival of patients treated with this regimen.\n\nOUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate.\n\nPatients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 4 courses. Patients also receive oral imatinib mesylate daily continually for one week prior to, during, and after chemotherapy in the absence of 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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose (one dose level below the MTD).\n\nPROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed extensive stage small cell lung cancer\n\n * Incurable but amenable to treatment with chemotherapy\n * c-kit positive by immunohistochemistry of original biopsy or other metastatic site\n* At least one unidimensionally measurable lesion\n\n * \\> 20 mm by conventional techniques or \\> 10 mm by spiral CT scan\n * No prior radiotherapy to target measurable lesion(s), unless there is documented disease progression\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-1 OR\n* Karnofsky 70-100%\n\nLife expectancy\n\n* More than 6 weeks\n\nHematopoietic\n\n* WBC ≥ 3,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin normal\n* AST and/or ALT ≤ 2.5 times upper limit of normal\n\nRenal\n\n* Creatinine normal OR\n* Creatinine clearance ≥ 60 mL/min\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nGastrointestinal\n\n* No concurrent untreated upper gastrointestinal bleeding that has not been fully investigated\n* No gastrointestinal disease that would impair drug absorption\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception prior to, during, and for 3 months after study participation\n* No history of ototoxicity\n* No history of peripheral neuropathy\n* No traumatic injury within the past 21 days\n* No ongoing or active infection\n* No other concurrent significant medical condition that would preclude study participation\n* No concurrent psychiatric condition or social situation that would preclude study compliance\n* No other malignancy within the past 5 years except treated nonmelanoma skin cancer, carcinoma in situ, or stage A prostate cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* No prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy\n* No prior radiotherapy to more than 25% of marrow\n\nSurgery\n\n* More than 3 weeks since prior major surgery\n* No prior surgical procedure impairing absorption\n\nOther\n\n* No prior c-kit-targeted therapy\n* No concurrent therapeutic dose of warfarin\n\n * Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other concurrent investigational agents\n* No concurrent amifostine\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00052494', 'briefTitle': 'Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'PMH-PHL-008'}, 'secondaryIdInfos': [{'id': 'CDR0000258487', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-5684'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STI-571 with cisplatin and irinotecan', 'interventionNames': ['Drug: cisplatin', 'Drug: imatinib mesylate', 'Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'armGroupLabels': ['STI-571 with cisplatin and irinotecan']}, {'name': 'imatinib mesylate', 'type': 'DRUG', 'armGroupLabels': ['STI-571 with cisplatin and irinotecan']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['STI-571 with cisplatin and irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Mark D. Vincent, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}