Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT00033306
Status:
TERMINATED
Last Update Posted:
2013-08-05
First Post:
2002-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BMS-247550 in Treating Patients With Metastatic 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': 'C430592', 'term': 'ixabepilone'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2002-04-09', 'studyFirstSubmitQcDate': '2003-08-05', 'lastUpdatePostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.', 'timeFrame': 'baseline to survival'}], 'secondaryOutcomes': [{'measure': 'Determine the safety of this drug in these patients.', 'timeFrame': 'baseline to survival'}, {'measure': 'Determine the response duration, time to progression, and survival in patients treated with this drug.', 'timeFrame': 'baseline to survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV colon 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.\n\nPURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.\n* Determine the safety of this drug in these patients.\n* Determine the response duration, time to progression, and survival in patients treated with this drug.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive BMS-247550 IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4 additional courses of treatment beyond CR.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 19-55 patients will be accrued for this study within 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic colorectal adenocarcinoma\n* Prior treatment for metastatic disease with at least:\n\n * One regimen of irinotecan in combination with a fluoropyrimidine OR\n * Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy\n\n * May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy\n* Disease progression during or within 4 months of treatment with irinotecan\n* At least 1 bidimensionally measurable lesion\n* No known CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 2,000/mm\\^3\n* Platelet count greater than 125,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present)\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No New York Heart Association class III or IV heart disease\n* No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No known prior severe hypersensitivity reactions to agents containing Cremophor EL\n* No motor or sensory neuropathy grade 2 or greater\n* No concurrent serious uncontrolled infection or other nonmalignant medical illness\n* No concurrent psychiatric disorders or other conditions that would preclude study compliance\n* No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n* No concurrent immunotherapy\n* No growth factors for 24 hours before and after cytotoxic chemotherapy\n\nChemotherapy:\n\n* See Disease Characteristics\n* Additional prior adjuvant or neoadjuvant chemotherapy allowed\n* At least 4 weeks since prior chemotherapy and recovered\n* No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease\n* No prior oxaliplatin\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy except hormone replacement therapy\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy and recovered\n* No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy\n* No concurrent therapeutic radiotherapy\n\n * Focal radiotherapy for palliation of bone symptoms may be allowed\n\nSurgery:\n\n* At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered\n\nOther:\n\n* No other concurrent experimental anticancer medications'}, 'identificationModule': {'nctId': 'NCT00033306', 'briefTitle': 'BMS-247550 in Treating Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan', 'orgStudyIdInfo': {'id': 'CDR0000069272'}, 'secondaryIdInfos': [{'id': 'UAB-0145'}, {'id': 'BMS-CA163-012'}, {'id': 'UAB-F011029021'}, {'id': 'NCI-G02-2051'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-247550', 'interventionNames': ['Drug: ixabepilone', 'Drug: Fluoropyrimidine', 'Drug: Irinotecan']}], 'interventions': [{'name': 'ixabepilone', 'type': 'DRUG', 'armGroupLabels': ['BMS-247550']}, {'name': 'Fluoropyrimidine', 'type': 'DRUG', 'armGroupLabels': ['BMS-247550']}, {'name': 'Irinotecan', 'type': 'DRUG', 'armGroupLabels': ['BMS-247550']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Andres Forero-Torres, MD, CSU', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}