Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00017251
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C408162', 'term': 'oblimersen'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0', 'timeFrame': 'Up to 3 years', 'description': 'Data will be summarized separately for each dose level, by severity, and type of toxicity.'}, {'measure': 'Maximally tolerated dose of oblimersen sodium', 'timeFrame': '8 days'}], 'secondaryOutcomes': [{'measure': 'Potential antitumor activity (responses to therapy)', 'timeFrame': 'Up to 3 years', 'description': 'Will be analyzed using simple descriptive statistics only.'}, {'measure': 'Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level', 'timeFrame': 'Day 6 and 8', 'description': 'Will be analyzed using a paired t-test. If there are outliers or the distribution of changes in oblimersen sodium levels appears to be highly non-normal, the data will be analyzed using the Wilcoxon singed-rank test.'}]}, 'conditionsModule': {'conditions': ['Extensive Stage Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer.\n\nII. Determine the toxicity and feasibility of this regimen in these patients. III. Determine potential antitumor activity of this regimen as assessed by objective response in these patients.\n\nOUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).\n\nPatients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.\n\nCohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed extensive stage small cell lungcancer\n* No active CNS disease\n\n * CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy\n* Performance status - ECOG 0-2\n* Performance status - Karnofsky 60-100%\n* More than 2 months\n* WBC at least 3,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Bilirubin normal\n* AST and ALT no greater than 2.5 times upper limit of normal (ULN)\n* PT and PTT no greater than 1.5 times ULN\n* Creatinine normal\n* Creatinine clearance at least 60 mL/min\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No prior allergic reactions to compounds of similar chemical or biologic composition to study agents\n* No other uncontrolled concurrent illness\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* See Disease Characteristics\n* At least 1 week since prior CNS radiotherapy and recovered\n* No prior radiotherapy to more than 25% of skeleton\n* No other prior anticancer therapy\n* No other concurrent investigational agents\n* No other concurrent anticancer therapy\n* No concurrent anticoagulation therapy\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00017251', 'briefTitle': 'Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-02387'}, 'secondaryIdInfos': [{'id': '10992A'}, {'id': 'N01CM17102', 'link': 'https://reporter.nih.gov/quickSearch/N01CM17102', 'type': 'NIH'}, {'id': 'CDR0000068667', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (oblimersen sodium, carboplatin, etoposide)', 'description': 'Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.', 'interventionNames': ['Biological: oblimersen sodium', 'Drug: carboplatin', 'Drug: etoposide', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'oblimersen sodium', 'type': 'BIOLOGICAL', 'otherNames': ['augmerosen', 'G3139', 'G3139 bcl-2 antisense oligodeoxynucleotide', 'Genasense'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oblimersen sodium, carboplatin, etoposide)']}, {'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['Carboplat', 'CBDCA', 'JM-8', 'Paraplat', 'Paraplatin'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oblimersen sodium, carboplatin, etoposide)']}, {'name': 'etoposide', 'type': 'DRUG', 'otherNames': ['EPEG', 'VP-16', 'VP-16-213'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (oblimersen sodium, carboplatin, etoposide)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (oblimersen sodium, carboplatin, etoposide)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (oblimersen sodium, carboplatin, etoposide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Charles Rudin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}