Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 8:33 AM
Study NCT ID:
NCT00522795
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2007-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080406', 'term': 'protein phosphatase 4'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'C509139', 'term': 'paclitaxel poliglumex'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kayla_Rosati@brown.edu', 'phone': '401-863-3000', 'title': 'Kayla Rosati', 'organization': 'BrUOG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PPX, Cisplatin, Radiation', 'description': '* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.\n* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX', 'otherNumAtRisk': 40, 'otherNumAffected': 2, 'seriousNumAtRisk': 40, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'esophagitis, nauseam dehydration, electrolyte imbalance, potassium and mood alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'allergic reaction/hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea, dehydration, esophagitis, death', 'notes': 'death related to progressive disease and carcinoma meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'multiorgan failure', 'notes': 'post op esophagectomy 2 1/2 months post chemotherapy not related to chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leukopenia, esophagitis, dehydration, nausea, vomiting, neutropenia, hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycemia, dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infection of gallbladder with normal ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dysphagia, dizziness, dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypokalemia, hypomagnesemia, weakness, anorexia, opportunistic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombosis, hematoma, hypomagnesemia, extrapyramidal/restless', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea, vomiting, weakness, ischemic colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infection with normal ANC (cellulitis) and albumin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute vascular leak, GI other, hypotension, anorexia, hypothermia,INR', 'notes': 'GI other is abdominal compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain and dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Pathologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PPX, Cisplatin, Radiation'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Surgery approximately 4weeks after last treatment', 'description': 'Per pathology review post surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PPX, Cisplatin, Radiation', 'description': '* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.\n* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Accrual closed in August 2009, 40 patients were enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PPX, Cisplatin, Radiation', 'description': '* PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.\n* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2007-08-28', 'resultsFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2007-08-29', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-09', 'studyFirstPostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Pathologic Response', 'timeFrame': 'At Surgery approximately 4weeks after last treatment', 'description': 'Per pathology review post surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal Cancer'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001', 'detailedDescription': '32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction\n* Patients may have celiac adenopathy\n* There must be no evidence of distant organ metastases\n* No prior chemotherapy or radiation for esophageal cancer\n* Patients must be \\> 18 years of age, and non pregnant\n* Patients must have an ANC \\> 1,500/ul, platelets \\> 100,000/ul, creatinine \\< 2.0 and bilirubin \\< 1.5 x ULN-ECOG performance status 0-1.\n* Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible\n* No contraindications to esophagectomy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active or uncontrolled infection\n* Patients must not have other coexistent medical condition that would preclude protocol therapy.\n* Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).'}, 'identificationModule': {'nctId': 'NCT00522795', 'briefTitle': 'Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001', 'orgStudyIdInfo': {'id': 'BrUOG-E-215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPX with cisplatin and radiation', 'description': 'PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation', 'interventionNames': ['Drug: PPX with cisplatin and radiation']}], 'interventions': [{'name': 'PPX with cisplatin and radiation', 'type': 'DRUG', 'otherNames': ['Paclitaxel Poliglumex, Cisplatin and radiation'], 'description': 'weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks', 'armGroupLabels': ['PPX with cisplatin and radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lifespan Hospitals', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Howard Safran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland Greenebaum Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'howard safran', 'investigatorAffiliation': 'Brown University'}}}}