Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-10 @ 3:49 PM
Study NCT ID:
NCT00031694
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2002-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'C046785', 'term': 'bryostatin 1'}, {'id': 'D054713', 'term': 'Bryostatins'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D000095702', 'term': 'Polyether Toxins'}, {'id': 'D000095662', 'term': 'Polyether Polyketides'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008387', 'term': 'Marine Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsparano@montefiore.org', 'phone': '718-405-8404', 'title': 'Joseph Sparano', 'organization': 'Montefiore Medical Center-New York cancer Consortium'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Paclitaxel, Bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV\n\nbryostatin 1: Given IV\n\npharmacological study: Correlative studies', 'otherNumAtRisk': 19, 'otherNumAffected': 7, 'seriousNumAtRisk': 19, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'ALT/SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'AST/SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate of at Least 30%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Paclitaxel, Bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV\n\nbryostatin 1: Given IV\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 years', 'description': 'Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'data not met'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Paclitaxel, Bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV\n\nbryostatin 1: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Paclitaxel, Bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV\n\nbryostatin 1: Given IV\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 years', 'description': 'Computed using the Kaplan-Meier estimator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with locally advanced or metastatic pancreatic adenocarcinoma received a total of 52 cycles of therapy.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bryostatin 1 Pharmacokinetics', 'timeFrame': 'Week 1', 'description': 'Not done-study terminated early', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Paclitaxel, Bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV\n\nbryostatin 1: Given IV\n\npharmacological study: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'A total of 19 patients were enrolled from 5 centers between March 2002 and October 2003.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Paclitaxel, Bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV\n\nbryostatin 1: Given IV\n\npharmacological study: Correlative studies'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic whites', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Non-Hispanic black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', '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': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2002-03-08', 'resultsFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-08', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bryostatin 1 Pharmacokinetics', 'timeFrame': 'Week 1', 'description': 'Not done-study terminated early'}], 'primaryOutcomes': [{'measure': 'Response Rate of at Least 30%', 'timeFrame': 'Up to 8 years', 'description': 'Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to 8 years'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 8 years', 'description': 'Computed using the Kaplan-Meier estimator.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acinar Cell Adenocarcinoma of the Pancreas', 'Duct Cell Adenocarcinoma of the Pancreas', 'Recurrent Pancreatic Cancer', 'Stage III Pancreatic Cancer', 'Stage IV Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '19738452', 'type': 'RESULT', 'citation': 'Lam AP, Sparano JA, Vinciguerra V, Ocean AJ, Christos P, Hochster H, Camacho F, Goel S, Mani S, Kaubisch A. Phase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma. Am J Clin Oncol. 2010 Apr;33(2):121-4. doi: 10.1097/COC.0b013e3181a31920.'}]}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.\n\nII. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic\n* Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy;\n* Measurable disease\n* ECOG performance status of 0-1\n* Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital\n* Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study\n* Absolute granulocytes \\> 1,500/mm\\^3\n* Platelets \\> 150,000/mm\\^3\n* Serum bilirubin \\< 1.5 mg/dl\n* Serum creatinine \\< 1.5 mg/dl\n\nExclusion Criteria:\n\n* Presence of any ongoing toxic effect from prior treatment\n* Brain metastases\n* History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted\n* Pregnant or lactating women\n* Pre-existing neurotoxicity that is graded 3+ or greater\n* Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy\n* Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol\n* HIV infection\n* Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)"}, 'identificationModule': {'nctId': 'NCT00031694', 'briefTitle': 'Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-03003'}, 'secondaryIdInfos': [{'id': '01-09-224', 'type': 'OTHER', 'domain': 'Montefiore Medical Center'}, {'id': 'NCI-5624', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'N01CM17103', 'link': 'https://reporter.nih.gov/quickSearch/N01CM17103', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (paclitaxel, bryostatin 1)', 'description': 'Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: paclitaxel', 'Drug: bryostatin 1']}], 'interventions': [{'name': 'paclitaxel', 'type': 'DRUG', 'otherNames': ['Anzatax', 'Asotax', 'TAX', 'Taxol'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (paclitaxel, bryostatin 1)']}, {'name': 'bryostatin 1', 'type': 'DRUG', 'otherNames': ['B705008K112', 'BRYO', 'Bryostatin'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (paclitaxel, bryostatin 1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467-2490', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Andreas Kaubisch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}