Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-28 @ 5:25 PM
Study NCT ID:
NCT00089102
Status:
TERMINATED
Last Update Posted:
2018-07-16
First Post:
2004-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077146', 'term': 'Irinotecan'}], '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'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anderton@musc.edu', 'phone': '843-792-2708', 'title': 'Kate Anderton', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From day 1 until end of study visit, an average of 6 months', 'description': 'Data for adverse events (non-serious) was not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'left pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Proportion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partial Response', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stable or Progressive Disease', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From registration until time of complete response or partial response', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated on study who underwent a response assessment'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle'}], 'timeFrame': 'From registration until disease progression among patients who had at least a partial response', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available for this endpoint was not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced SAEs on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle'}], 'classes': [{'categories': [{'title': 'Number of patients who experienced an SAE', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Number of patients who did not experience an SAE', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the day of first dose until the end of study, for an average of 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle'}], 'timeFrame': 'Time between registration and disease progression or death, whichever comes first.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this endpoint was not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemcitabine + Irinotecan', 'description': 'gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle\n\nirinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2004-08-04', 'resultsFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2004-08-04', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-13', 'studyFirstPostDateStruct': {'date': '2004-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Proportion', 'timeFrame': 'From registration until time of complete response or partial response'}], 'secondaryOutcomes': [{'measure': 'Duration of Response', 'timeFrame': 'From registration until disease progression among patients who had at least a partial response'}, {'measure': 'Number of Participants Who Experienced SAEs on Study', 'timeFrame': 'From the day of first dose until the end of study, for an average of 6 months'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Time between registration and disease progression or death, whichever comes first.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent renal cell cancer', 'stage III renal cell cancer', 'stage IV renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced unresectable or metastatic kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma treated with gemcitabine and irinotecan.\n\nSecondary\n\n* Determine the duration of response in patients treated with this regimen.\n* Determine the tolerance to and toxicity of this regimen in these patients.\n* Determine median and progression-free survival in patients treated with this regimen.\n\nOUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond best response.\n\nPatients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed renal cell carcinoma\n\n * Locally advanced unresectable or metastatic disease\n* Unidimensionally measurable disease by physical exam or imaging study\n\n * The following are not considered measurable disease:\n\n * Bone only disease\n * Pleural or peritoneal effusions\n * CNS lesions\n * Irradiated lesions unless disease progression was documented after radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* ALT and AST \\< 3 times upper limit of normal\n* Bilirubin ≤ 2.0 mg/dL\n\nRenal\n\n* Creatinine ≤ 2.0 mg/dL\n\nGastrointestinal\n\n* No active inflammatory bowel disease\n* No significant bowel obstruction\n* No chronic diarrhea\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study participation\n* No mental incapacitation or psychiatric illness that would preclude giving informed consent\n* No other active malignancy except nonmelanoma skin cancer\n* No other severe disease that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 4 weeks since prior immunotherapy\n* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)\n\nChemotherapy\n\n* No prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n* No concurrent palliative radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00089102', 'briefTitle': 'Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000378044'}, 'secondaryIdInfos': [{'id': 'MUSC-100730'}, {'id': 'MUSC-HR-10981'}, {'id': 'PHARMACIA-B9E-US-X388'}, {'id': 'LILLY-MUSC-100730'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine + Irinotecan', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': '1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle', 'armGroupLabels': ['Gemcitabine + Irinotecan']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'description': '100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle', 'armGroupLabels': ['Gemcitabine + Irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hollings Cancer Center at Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Regional Cancer Center at Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Uzair B. Chaudhary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Gustavo Leone', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of South Carolina, Hollings Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}