Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-03 @ 7:18 PM
Study NCT ID:
NCT01434459
Status:
TERMINATED
Last Update Posted:
2015-05-04
First Post:
2011-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], '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'}, {'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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'PI moved to different institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-01', 'studyFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2011-09-14', 'lastUpdatePostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum tolerated dose of gemcitabine when given in combination with therasphere', 'timeFrame': '28 days', 'description': 'Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.'}], 'secondaryOutcomes': [{'measure': 'Toxicities (side effects) experienced by patients on the trial', 'timeFrame': '90 days', 'description': 'Any side effect experienced on the trial will be graded according to the grading system developed by the national cancer institute. The number of patients with each side effect will be calculated.'}, {'measure': 'Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .', 'timeFrame': '78 days', 'description': 'Patients will receive a PET CT prior to treatment and then another PET CT scan at completion day 78. Comparison of tumor size and uptake of FDG will be performed using standard RECIST criteria'}, {'measure': 'The progression free of patients treated on the trial', 'timeFrame': '12 months', 'description': 'The investigators will follow patients with serial cross sectional (CT or MRI) scans. If the tumor shows growth on the scan then the investigators will calculate the time it took for the tumor to grow.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic neoplasms', 'Cholangiocarcinoma'], 'conditions': ['Pancreatic Neoplasms', 'Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': "Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer.\n\nThe investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.", 'detailedDescription': 'Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma\n2. Liver predominant disease defined as\n\n \\- Cholangiocarcinoma: liver disease should be unresectable\n\n \\- Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm.\n\n ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis\n3. No prior systemic therapy for advanced stage disease\n4. Measurable target tumors using standard imaging techniques\n5. Lung shunting less than 20%\n6. ECOG performance status 0-1 (See Appendix )\n7. Age ≥ 18 years\n8. No other investigational agents while on protocol\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Inadequate hepatic function: AST/ALT \\> five times upper limit of normal, Bilirubin \\>2.0 mg/dl or history of hepatic encephalopathy\n2. Inadequate renal function Creatinine \\> 2.0 mg/dL\n3. Inadequate bone marrow function: platelets \\< 100,000/mL or absolute neutrophil count \\<1500/mL\n4. Contraindication to angiography\n5. Prior external beam radiotherapy to the upper abdomen\n6. Clinical evidence of peritoneal metastasis or ascites\n7. Patients with extensive tumor replacement in the liver defined as \\>50% of liver involved with tumor\n8. Any serious ongoing extra-hepatic disease such as infections.'}, 'identificationModule': {'nctId': 'NCT01434459', 'briefTitle': 'Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin', 'orgStudyIdInfo': {'id': 'IRB00047233a'}, 'secondaryIdInfos': [{'id': 'WCI1907-10', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine with TheraSphere', 'interventionNames': ['Drug: Gemcitabine with TheraSphere']}], 'interventions': [{'name': 'Gemcitabine with TheraSphere', 'type': 'DRUG', 'otherNames': ['TheraSphere_radioembolization', 'Gemcitabine- Gemzar'], 'description': 'Gemcitabine dose will be escalated and combined with therasphere.', 'armGroupLabels': ['Gemcitabine with TheraSphere']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Hyun Kevin Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Winship Cancer Institute'}, {'name': 'Bassel El-Rayes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Winship Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bassel El-Rayes', 'investigatorAffiliation': 'Emory University'}}}}