Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-04-13 @ 2:03 AM
Study NCT ID:
NCT00983268
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077337', 'term': 'Vorinostat'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy', 'timeFrame': 'Two weeks after completing radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Toxicity as assessed by NCI CTCAE v3.0', 'timeFrame': 'Six weeks after completing chemo-radiation therpay'}, {'measure': 'Tumor response as assessed by RECIST criteria', 'timeFrame': 'Six weeks after completing chemo-radiation therpay'}, {'measure': 'Biological effect', 'timeFrame': 'Six weeks after completing chemo-radiation therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['periampullary adenocarcinoma', 'stage I pancreatic cancer', 'stage II pancreatic cancer', 'stage III pancreatic cancer'], 'conditions': ['Pancreatic Cancer', 'Periampullary Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vicc.org/ct/', 'label': 'Vanderbilt-Ingram Cancer Center, Find a Clinical Trial'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving capecitabine and vorinostat together with radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with capecitabine and radiation therapy in treating patients with nonmetastatic pancreatic cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of vorinostat when given in combination with capecitabine and high-dose hypofractionated radiotherapy in patients with nonmetastatic pancreatic cancer.\n\nSecondary\n\n* Determine the safety and side effect profile of this regimen in these patients.\n* Determine the response rate in patients treated with this regimen.\n\nCorrelative\n\n* Compare pre- and post-treatment whole-cell HDAC-activity levels in peripheral blood mononuclear cell samples.\n* Assess chromatin structure and DNA damage in surgical tumor tissue samples.\n* Assess proliferation and apoptosis by in vivo imaging.\n\nOUTLINE: This is a dose-escalation study of vorinostat.\n\nPatients receive oral capecitabine twice daily and undergo high-dose hypofractionated radiotherapy once daily on days 1-5 and 8-12. Patients also receive oral vorinostat once daily on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity.\n\nPatients are evaluated for surgery within 6 weeks after completion of chemoradiotherapy. Patients with resectable disease proceed to surgery. Patients with unresectable disease may receive oral vorinostat once daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nBlood samples are collected periodically for correlative laboratory studies. Patients also undergo diffusion-weighted MRI for analysis of in vivo tumor cellularity.\n\nAfter completion of study therapy, patients are followed up periodically for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have histologically confirmed pancreatic or periampullary cancer.\n* Patient must be \\> 18 years of age.\n* Patient may be resectable, borderline resectable, or unresectable but locally advanced as determined by radiographic examination and consultation with a surgical oncologist.\n* Patient must have Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.\n* Female patients of childbearing potential must be willing to use birth control. The 2 birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with visit 1. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner) or sponge. Other methods of contraception such as copper intrauterine device or spermicide may be used. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).Female patient of childbearing potential has a negative serum pregnancy test β-hCG within 7 days prior to receiving the first dose of vorinostat.\n* Male patients agree to use an adequate method of contraception for the duration of the study.\n* Patient has a life expectancy of at least 12 weeks\n* Patient must have adequate organ function as indicated by the following laboratory values:\n* Absolute neutrophil count (ANC) ≥1,500 /mcL\n* Platelets ≥100,000 / mcL Hemoglobin ≥ 9 g/dL\n* Coagulation\n* Prothrombin Time or INR ≤1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation\n* Partial thromboplastin time (PTT) ≤1.2 times the ULN unless the patient is receiving therapeutic anticoagulation.\n* K levels - Normal limits\n* Mg levels - Normal limits\n* Calculated creatinine \\*clearance ≥20 mL/min\n* Serum total bilirubin ≤ 1.5 X ULN\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN\n* Alkaline Phosphatase ≤ 2.5 X ULN\n\n \\* Creatinine clearance should be calculated per institutional standard.\n* Patient must be capable of understanding and complying with the study protocol and able to give informed consent.\n* Measurable disease is not an eligibility requirement.\n\nExclusion Criteria:\n\n* Prior chemotherapy for pancreatic or periampullary cancer.\n* Prior radiation to any area within the planned radiation field. All patients with history of prior radiation to any area must be approved by PI.\n* Evidence of distant metastases on imaging.\n* History of hypersensitivity to fluoropyrimidines or HDACs.'}, 'identificationModule': {'nctId': 'NCT00983268', 'briefTitle': 'Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.', 'orgStudyIdInfo': {'id': 'VICC GI 0934'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-GI-0934'}, {'id': 'IRB# 090791'}, {'id': 'NCCN-M02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'interventionNames': ['Drug: capecitabine', 'Drug: vorinostat', 'Radiation: Radiotherapy', 'Procedure: Surgery to remove tumor']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': '1000 mg taken by mouth on the days of radiation only.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'vorinostat', 'type': 'DRUG', 'description': 'Vorinostat will be given by mouth on the day of radiation and then Monday-Friday for two weeks after radiation in these 4 possible doses:\n\n* Vorinostat,at 100 mg\n* Vorinostat,at 200 mg\n* Vorinostat, at 300 mg\n* Vorinostat, at 400 mg', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'High-dose hypofractionated radiotherapy consisting of 3000 cGy in 10 fractions, Monday-Friday for 2 weeks.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Surgery to remove tumor', 'type': 'PROCEDURE', 'description': 'Patients will be assessed for resectability within six weeks of the end of chemoradiation, if resectable, surgery will be performed.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Emily Chan, M.D, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Comprehensive Cancer Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Medical Oncologist', 'investigatorFullName': 'Emily Chan, MD, PhD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}