Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00336960
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2006-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-02', 'studyFirstSubmitDate': '2006-06-13', 'studyFirstSubmitQcDate': '2006-06-13', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic complete response rate', 'timeFrame': 'at time of surgery, day 5'}], 'secondaryOutcomes': [{'measure': 'Complete resection rate', 'timeFrame': 'at time of surgery, day 5'}, {'measure': 'Patterns of failure', 'timeFrame': 'during study, beginning day 5 forward'}, {'measure': 'Survival', 'timeFrame': 'at time of death'}, {'measure': 'Toxicity', 'timeFrame': '5 days before surgery & 5 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II rectal cancer', 'stage III rectal cancer', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.\n\nPURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and radiotherapy.\n* Determine whether administration of celecoxib, a COX-2 inhibitor, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in the surrounding normal tissue.\n* Determine if there is a greater change in protein and gene expression in post-treatment biopsies when compared to pretreatment biopsies that are greater for tumor (COX-2 overexpression) than in surrounding normal tissue.\n* Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy.\n* Assess the toxicities of concurrent treatment with celecoxib, fluorouracil, and radiotherapy.\n\nOUTLINE: This is a pilot study.\n\nPatients receive oral celecoxib twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive concurrent fluorouracil IV continuously for 5 weeks. Patients undergo radical resection 4-10 weeks after completion of chemoradiotherapy.\n\nPatients undergo tumor biopsy at baseline and then at the time of surgical resection. Patients also undergo blood and urine collection at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. The specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.\n\nAfter completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary adenocarcinoma of the rectum\n\n * Stage II or III disease\n* Distal border of tumor must be at or below the peritoneal reflection\n\n * Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam\n* Tumor must be clinically resectable\n* Transmural penetration beyond muscularis propria by transrectal ultrasound\n* No high-grade obstruction\n* No evidence of metastatic 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 or psychiatric condition that would preclude study treatment\n* No history of allergy to celecoxib or any other NSAIDs\n* No history of allergy to sulfonamides\n* No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior radiotherapy to the pelvis\n* At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)\n* No concurrent warfarin except low-dose warfarin (1 mg/day)'}, 'identificationModule': {'nctId': 'NCT00336960', 'briefTitle': 'Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Phase II Pilot Study of Pre-Operative Celecoxib (Celebrex) in Combination With Prolonged Venous Infusion 5FU and Radiation Therapy for Patients With Stage II/III Resectable Rectal Cancer', 'orgStudyIdInfo': {'id': 'VICC GI 0173'}, 'secondaryIdInfos': [{'id': 'P50CA095103', 'link': 'https://reporter.nih.gov/quickSearch/P50CA095103', 'type': 'NIH'}, {'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VICC-GI-0173'}, {'id': 'VICC-020031'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment intervention', 'interventionNames': ['Drug: celecoxib', 'Drug: fluorouracil', 'Procedure: conventional surgery', 'Radiation: radiation therapy', 'Procedure: tumor biopsy', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'celecoxib', 'type': 'DRUG', 'description': 'twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy', 'armGroupLabels': ['treatment intervention']}, {'name': 'fluorouracil', 'type': 'DRUG', 'description': 'Patients receive concurrent fluorouracil IV continuously for 5 weeks.', 'armGroupLabels': ['treatment intervention']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'description': '4-10 weeks after completion of chemoradiotherapy', 'armGroupLabels': ['treatment intervention']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Patients undergo radiotherapy 5 days a week for 5 weeks', 'armGroupLabels': ['treatment intervention']}, {'name': 'tumor biopsy', 'type': 'PROCEDURE', 'description': 'at baseline and then at the time of surgical resection', 'armGroupLabels': ['treatment intervention']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.', 'armGroupLabels': ['treatment intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-5671', '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'}}}}