Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 6:05 AM
Study NCT ID:
NCT00006103
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2000-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2003-09-02', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'Up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage III colon cancer', 'stage IV colon cancer', 'stage III rectal cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background.\n\nPURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil in treating patients from different racial backgrounds who have colorectal cancer that is advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the interracial differences in the pharmacokinetics of irinotecan in combination with fluorouracil in terms of SN-38 glucuronidation and biliary index, and gastrointestinal (GI) toxicity in patients with metastatic, locally advanced, or recurrent colorectal cancer.\n* Determine if there is a significant relationship between UGT1A1 genotype (promoter and/or coding region mutation) and CYP3A4 promoter genotype, vs GI toxicity, bone marrow toxicity, and pharmacokinetics of irinotecan in this patient population.\n\nOUTLINE: Patients are stratified according to race (Asian or Pacific Islander vs black vs Hispanic vs white).\n\nPatients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 400 patients (100 per stratum) will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon or rectum\n\n * Metastatic, locally advanced, or recurrent disease\n* Patients must have at least 2 generations (parents and grandparents) who belong to one of the following racial groups:\n\n * Asian or Pacific Islander (e.g., China, Japan, Korea, the Philippine Islands, or Samoa)\n * Black (originating from the black racial groups of Africa)\n * Hispanic (originating from Mexico, Puerto Rico, Cuba, Central or South America, or other Spanish culture)\n * White (originating from the peoples of Europe, North Africa, or the Middle East)\n* No patients with parents or grandparents of mixed race or race other than that of the patient\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* CTC 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Granulocyte count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* AST no greater than 3 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior adjuvant fluorouracil allowed if relapse occurred at least 6 months after completion of fluorouracil\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\n* No prior irinotecan\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic\n* No concurrent prednisone\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy (except to bone or soft tissue involving less than 25% of bone marrow)\n* No concurrent radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior major surgery\n\nOther:\n\n* No concurrent phenobarbital, valproate, or cyclosporine\n* None of the following concurrently during first course of therapy:\n\n * Macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin, troleandomycin, dapsone)\n * Azole antibiotics (e.g., fuconazole, miconazole, itraconazole, ketoconazole)\n * Triazobenzodiazepines (e.g., alprazolam, midazolam, triazolam)\n * Antidepressants (e.g., fluoxetine, setraline hydrochloride, fluoxamine, nefazodone hydrochloride)\n * Quinolone antimicrobials (e.g., ciprofloxacin, ofloxacin)\n * Imidazole antibiotics (e.g., clotrimazole)\n * Anti-ulcer medications (e.g., omeprazole, lansoprazole)\n * Ethinyl estradiol\n * Diltiazem\n * Cimetidine hydrochloride\n * Cisapride\n * Terfenadine\n * Rifampin\n * Glucocorticoids\n * Antiepileptics\n * Grapefruit juice'}, 'identificationModule': {'nctId': 'NCT00006103', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Interracial Study of CPT-11 (Irinotecan) Pharmacokinetics in 5-Fluorouracil Refractory Colorectal Cancer: A Population Pharmacokinetic/Pharmacodynamic Study of CPT-11', 'orgStudyIdInfo': {'id': 'CALGB-9864'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CLB-9864'}, {'id': 'E-C9864'}, {'id': 'CDR0000068113', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'irinotecan + leucovorin + fluorouracil', 'description': 'Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year and then every 6 months thereafter.', 'interventionNames': ['Drug: fluorouracil', 'Drug: irinotecan hydrochloride', 'Drug: leucovorin calcium']}], 'interventions': [{'name': 'fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + leucovorin + fluorouracil']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + leucovorin + fluorouracil']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'armGroupLabels': ['irinotecan + leucovorin + fluorouracil']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Brian Leyland-Jones, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'McGill Cancer Centre at McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}