Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-28 @ 6:32 PM
Study NCT ID:
NCT00557102
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2007-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
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': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2007-11-09', 'studyFirstSubmitQcDate': '2007-11-09', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response rate', 'timeFrame': 'From baseline to end of treatment'}], 'secondaryOutcomes': [{'measure': 'Rate of resectability', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'Overall and disease-free survival', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'Tolerability', 'timeFrame': 'From baseline to end of treatment'}]}, 'conditionsModule': {'keywords': ['liver metastases', 'lung metastases', 'recurrent rectal cancer', 'stage IV rectal cancer', 'adenocarcinoma of the rectum', 'adenocarcinoma of the colon', 'recurrent colon cancer', 'stage IV colon cancer'], 'conditions': ['Colorectal Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.\n\nSecondary\n\n* Determine the rate of resectability in patients treated with this regimen.\n* Determine the overall and disease-free survival of patients treated with this regimen.\n* Determine the tolerability of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI chemotherapy, patients with responding disease undergo surgical resection of visceral metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon or rectum\n* Must have synchronous or metasynchronous unresectable hepatic metastases\n\n * Less than 8 hepatic metastases\n * Less than 6 segments of liver involvement with metastases\n* No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases\n* Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible\n* At least 1 measurable metastasis by CT scan or MRI\n* No brain metastases, bone metastases, or carcinomatous meningitis\n* No celiac lymph node involvement or peritoneal cancer\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-1\n* Life expectancy \\> 3 months\n* ANC ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* PT rate \\> 70%\n* Bilirubin \\< 30 μmol/L\n* Creatinine \\< 130 μmol/L\n* Creatinine clearance \\> 60 mL/min\n* Not pregnant or nursing\n* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix\n* No severe unstable angina\n* No symptomatic heart failure\n* No other concurrent illness\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 3 months since prior adjuvant anticancer chemotherapy\n* No concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00557102', 'acronym': 'ERBIFORT', 'briefTitle': 'Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Institute, France'}, 'officialTitle': 'Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX', 'orgStudyIdInfo': {'id': 'CDR0000574153'}, 'secondaryIdInfos': [{'id': 'CHUG-ERBIFORT'}, {'id': 'INCA-RECF0316'}, {'id': 'EUDRACT-2007-000357-54'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cetuximab, FOLFIRI', 'interventionNames': ['Biological: cetuximab', 'Biological: filgrastim', 'Drug: fluorouracil', 'Drug: irinotecan hydrochloride', 'Drug: leucovorin calcium']}], 'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['cetuximab, FOLFIRI']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['cetuximab, FOLFIRI']}, {'name': 'fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['cetuximab, FOLFIRI']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['cetuximab, FOLFIRI']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'armGroupLabels': ['cetuximab, FOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Hopital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean Marc Phelip, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Hospital, Grenoble', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}