Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-21 @ 6:46 PM
Study NCT ID:
NCT00608595
Status:
TERMINATED
Last Update Posted:
2013-03-05
First Post:
2008-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Treating Patients With Early-Stage Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D013058', 'term': 'Mass Spectrometry'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-02', 'studyFirstSubmitDate': '2008-01-30', 'studyFirstSubmitQcDate': '2008-02-02', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event rate of over-expression of cyclooxygenase-2', 'timeFrame': 'Pre and post 7 days administration of study drug'}, {'measure': 'Percent change of eicosanoid level', 'timeFrame': 'Pre and post celecoxib treatment ratio of eicosanoid production'}, {'measure': 'Percent change of VEGF and prostaglandin-M levels', 'timeFrame': 'Pre and post celecoxib treatment VEGF and PGE-M levels'}, {'measure': 'Change of gene and protein expression pattern from pre- to post-treatment levels', 'timeFrame': 'Pre and post celecoxib treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the rectum', 'recurrent rectal cancer', 'stage I rectal cancer', 'stage II rectal cancer', 'stage III rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib.\n\nPURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine cyclooxygenase-2 (COX-2) over-expression in tumor specimens from patients with early-stage rectal cancer.\n* Determine whether administration of a COX-2 inhibitor, celecoxib, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in levels in the surrounding normal tissue that is expected not to express COX-2.\n* Determine whether surrogate markers of eicosanoid metabolism (i.e., serum VEGF levels, tumor prostaglandin E\\_2 \\[PGE\\_2\\], and the major urinary metabolite of PGE\\_2 \\[PGE-M\\]) in biological specimens from these patients correlate with changes noted in tumor tissue.\n* Determine if there is a greater change in protein and gene expression from pretreatment biopsy levels in patient tumor specimens (COX-2 overexpressing) vs specimens of surrounding normal tissue (expected not to be COX-2 overexpressing).\n\nOUTLINE: Patients receive oral celecoxib twice daily on days 1-5. Patients then undergo planned local excision or definitive radical resection on day 6.\n\nTumor tissue and normal tissue (at least 5 cm away from the tumor) samples are collected pretreatment. Post-treatment tissue samples are collected along with the surgery. Serum and urine samples are obtained at baseline and after administration of celecoxib. Tumor and normal tissue specimens are analyzed by assays measuring markers of cyclooxygenase-2 (COX-2) activity (i.e., COX-2 mRNA and protein, tumor prostaglandin E\\_2 \\[PGE\\_2\\], and VEGF). Tissue samples are also assessed by cDNA microarray and imaging mass spectrometry to determine overall changes in gene and protein expression from pretreatment levels. Surrogate markers of COX-2 activity in serum (i.e., VEGF) and urine (i.e., urinary metabolite of PGE\\_2 \\[PGE-M\\]) are also assessed and compared with changes noted in tumor tissue. COX-2 protein levels are determined by immunohistochemistry in patients with limited pretreatment tumor tissue specimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)\n\n * Tumor must be at or below the peritoneal reflection\n * The distal border of the tumor is within 12 cm of the anal verge on proctoscopic examination\n* Clinically resectable disease\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* WBC ≥ 4,000/mm³\n* Platelet count ≥ 150,000/mm³\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other serious medical illness (other than rectal cancer) that would preclude study therapy\n* No psychiatric condition that would preclude informed consent\n* No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic acid (i.e., aspirin), ibuprofen, or indomethacin\n* No history of allergy to sulfonamides\n\nExclusion criteria:\n\nNot noted\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors\n* No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis'}, 'identificationModule': {'nctId': 'NCT00608595', 'briefTitle': 'Celecoxib in Treating Patients With Early-Stage Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)', 'orgStudyIdInfo': {'id': 'VICC GI 0174'}, 'secondaryIdInfos': [{'id': 'VU-VICC-GI-0174'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Intervention/Celecoxib', 'description': 'Celecoxib', 'interventionNames': ['Drug: celecoxib', 'Genetic: gene expression analysis', 'Genetic: protein expression analysis', 'Other: immunohistochemistry staining method', 'Other: laboratory biomarker analysis', 'Other: mass spectrometry', 'Procedure: biopsy', 'Procedure: neoadjuvant therapy', 'Procedure: therapeutic conventional surgery']}], 'interventions': [{'name': 'celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'gene expression analysis', 'type': 'GENETIC', 'description': 'not noted', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'protein expression analysis', 'type': 'GENETIC', 'description': 'Not noted', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'description': 'not noted', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'not noted', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'mass spectrometry', 'type': 'OTHER', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'biopsy', 'type': 'PROCEDURE', 'description': 'At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE', 'description': 'not noted', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'not noted', 'armGroupLabels': ['Therapeutic Intervention/Celecoxib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Veterans Administration', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'A. Bapsi Chakravarthy, MD', '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'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Medical Oncologist', 'investigatorFullName': 'A Bapsi Chakravarthy, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}