Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00408551
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2006-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D003110', 'term': 'Colonic 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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005467', 'term': 'Floxuridine'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D003857', 'term': 'Deoxyuridine'}, {'id': 'D014529', 'term': 'Uridine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-06', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan'}, {'measure': 'Hepatic toxicity'}], 'secondaryOutcomes': [{'measure': 'Therapeutic efficacy based on time from selective internal radiation therapy (SIRT) to in-liver disease progression'}, {'measure': 'Therapeutic efficacy based on the proportion of patients who achieve down-staging among all chemo-SIRT treated patients'}]}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'liver metastases', 'recurrent colon cancer', 'recurrent rectal cancer'], 'conditions': ['Colorectal Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with internal radiation may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving chemotherapy together with internal radiation works in treating patients with colorectal cancer that has spread to the liver.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the tumor response, as measured by total tumor mass, carcinoembryonic antigen (CEA) level, measurable tumor volume by CT scan, and metabolic response by positron emission tomography (PET) scan, in patients with colorectal cancer metastatic to the liver undergoing chemotherapy and selective internal radiation therapy (SIRT) comprising yttrium Y 90 resin microspheres.\n* Evaluate the hepatic toxicity of this regimen, as measured by ALT, alkaline phosphatase, and bilirubin levels, in these patients.\n\nSecondary\n\n* Evaluate the therapeutic efficacy of this regimen, using time to in-liver disease progression as an end point, in these patients.\n* Evaluate the therapeutic efficacy of this regimen, using down-staging to resectability as an end point, in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive 1 of the following chemotherapy regimens:\n\n* FOLFOX6: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1.\n* FOLFIRI: Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1.\n* FUDR: Patients receive floxuridine IV continuously on days 1-14. In all chemotherapy regimens, treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients also undergo selective internal radiation therapy (SIRT) comprising yttrium Y 90 resin microspheres on day 2 of chemotherapy course 1 (for patients receiving FOLFOX6 or FOLFIRI chemotherapy regimens) or on day 1, 2, 3, 4, or 5 of course 1 (for patients receiving FUDR chemotherapy regimen). SIRT may repeat in week 10 or 12.\n\nIn week 18, patients may undergo surgery if down-staging has occurred or they may receive more chemotherapy.\n\nAfter completion of study therapy, patients are followed every 3 months for up to 2 years.\n\nPROJECTED ACCRUAL: A total of 20 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 or cytologically confirmed colorectal cancer\\* meeting 1 of the following criteria:\n\n * Metachronous metastasis after resection of Dukes A-C (i.e., stage I-III) primary colon cancer with or without adjuvant chemotherapy\n * Metachronous metastasis after resection of primary rectal cancer with neoadjuvant or adjuvant chemotherapy\n * Synchronous metastatic liver disease with symptomatic or asymptomatic primary colorectal cancer NOTE: \\*If the patient has a second malignancy with liver metastasis potential, histologic or cytologic confirmation of the liver lesions may be performed as clinically indicated\n* Liver-only or liver-predominant disease with any of the following:\n\n * Unresected primary disease\n * Limited bone or lung disease\n * Potentially resectable nodal disease\n * Anastomotic disease\n* No active CNS metastasis or diffuse peritoneal metastasis\n* No hepatic metastases from a second malignancy\n* No predominant extrahepatic disease\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy \\> 3 months\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9 g/dL\n* WBC ≥ 1,500/mm\\^3\n* Creatinine ≤ 2 mg/dL\n* Bilirubin ≤ 2 mg/dL (without extrahepatic biliary obstruction)\n* Albumin \\> 2 g/dL\n* INR \\< 1.5 (without anticoagulation)\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior external-beam radiotherapy to the liver\n* Concurrent targeted therapy agents (e.g., bevacizumab or cetuximab) allowed'}, 'identificationModule': {'nctId': 'NCT00408551', 'briefTitle': 'Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Multi-Institutional Efficacy and Safety Study of Chemotherapy With Selective Internal Radiation Treatment Using Y-90 Microspheres (CHEMO-SIRT) in Patients With Colorectal Cancer Liver Metastasis', 'orgStudyIdInfo': {'id': 'CDR0000515900'}, 'secondaryIdInfos': [{'id': 'CCCGHS-CHEMO-SIRT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFOX6', 'description': 'Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1.', 'interventionNames': ['Drug: fluorouracil', 'Drug: leucovorin calcium', 'Drug: oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'FOLFIRI', 'description': 'Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1.', 'interventionNames': ['Drug: fluorouracil', 'Drug: irinotecan hydrochloride', 'Drug: leucovorin calcium']}, {'type': 'EXPERIMENTAL', 'label': 'FUDR', 'description': 'Patients receive floxuridine IV continuously on days 1-14.', 'interventionNames': ['Drug: floxuridine']}], 'interventions': [{'name': 'floxuridine', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['FUDR']}, {'name': 'fluorouracil', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['FOLFIRI', 'FOLFOX6']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['FOLFIRI']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['FOLFIRI', 'FOLFOX6']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['FOLFOX6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Office - Center for Cancer Care at Goshen Gene', 'role': 'CONTACT', 'phone': '574-535-2858'}], 'facility': 'Center for Cancer Care at Goshen General Hospital', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}], 'overallOfficials': [{'name': 'Kenneth L. Pennington, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Goshen Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goshen Health System', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kenneth Lee Pennington', 'oldOrganization': 'Center for Cancer Care at Goshen General Hospital'}}}}