Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT00083161
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2004-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cisplatin, Etoposide, and Cyclophosphamide 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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-01', 'studyFirstSubmitDate': '2004-05-14', 'studyFirstSubmitQcDate': '2004-05-14', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'From time of registration to 30 days post treatment of last cycle.'}, {'measure': 'Effect of metronomic chemotherapy on circulating endothelial cells', 'timeFrame': 'Baseline to progression', 'description': 'Collected cycle 1/day 1 of chemotherapy, Cycle 1/day 8, cycle 1/day 22, and then day 85 and 141, and at disease progression.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Registration to time of progression'}, {'measure': 'Response rate', 'timeFrame': 'From Registration to time of disease progression'}, {'measure': 'Overall survival', 'timeFrame': 'From registration to time patient expires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['extensive stage small cell lung cancer', 'recurrent small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with extensive stage small cell lung cancer.\n* Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients.\n\nSecondary\n\n* Determine progression-free survival, tumor response rate, and overall survival in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\n* Induction therapy: Patients receive cisplatin IV over 30 minutes-2 hours on day 1, etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily on days 2-3, and oral cyclophosphamide twice daily on days 8-19. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n* Maintenance therapy: Patients receive oral cyclophosphamide twice daily in the absence of disease progression.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed small cell lung cancer\n\n * Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field)\n* Measurable disease\n* Concurrent CNS metastases allowed provided patient remains asymptomatic\n\n * Radiotherapy or surgery for uncontrolled symptoms allowed before study entry\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 8 g/dL (transfusion allowed)\n\nHepatic\n\n* ALT ≤ 2 times upper limit of normal (ULN)\n* Bilirubin ≤ 2 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL OR\n* Creatinine clearance ≥ 60 mL/min\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior biologic therapy\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* Concurrent corticosteroids for brain metastases allowed\n\nRadiotherapy\n\n* See Disease Characteristics\n* Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00083161', 'briefTitle': 'Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gundersen Lutheran Health System'}, 'officialTitle': 'Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CDR0000363799'}, 'secondaryIdInfos': [{'id': 'GLO-03-06-06'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral cyclophosphamide plus standard cisplatin with etoposide', 'description': '1. Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3\n2. Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles\n3. Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle', 'interventionNames': ['Drug: cisplatin', 'Drug: cyclophosphamide', 'Drug: etoposide']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'description': '60 mg/m2 IV day 1, every 21 days for 4 cycles.', 'armGroupLabels': ['Oral cyclophosphamide plus standard cisplatin with etoposide']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': '25 mg by mouth BID days 8-19 or each cycle x 4 cycles. After restaging (if no progression) maintenance cyclophosphamide alone 25 mg by mouth BID daily until disease progression', 'armGroupLabels': ['Oral cyclophosphamide plus standard cisplatin with etoposide']}, {'name': 'etoposide', 'type': 'DRUG', 'otherNames': ['VP-16'], 'description': '120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3', 'armGroupLabels': ['Oral cyclophosphamide plus standard cisplatin with etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran Center for Cancer and Blood', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Ronald S. Go, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gundersen Lutheran Center for Cancer and Blood'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gundersen Lutheran Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hematologist', 'investigatorFullName': 'Ronald Go', 'investigatorAffiliation': 'Gundersen Lutheran Health System'}}}}