Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-02 @ 4:32 AM
Study NCT ID:
NCT00077259
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2004-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory 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': 'C114026', 'term': 'desoxyepothilone B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2004-02-10', 'studyFirstSubmitQcDate': '2004-02-10', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent colon cancer', 'recurrent rectal cancer', 'stage III colon cancer', 'stage III rectal cancer', 'stage IV colon cancer', 'stage IV rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the antitumor activity of epothilone D as second-line treatment, in terms of objective response rate, in patients with advanced or metastatic refractory colorectal cancer.\n\nSecondary\n\n* Determine the safety of this drug in these patients.\n* Determine the response duration in patients responding to treatment with this drug.\n* Determine time to tumor progression and overall survival in patients treated with this drug.\n* Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 19-69 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 advanced or metastatic adenocarcinoma of the colon or rectum\n* Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination\n* Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease\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* Not specified\n\nHematopoietic\n\n* Hemoglobin ≥ 9 g/dL\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)\n* Alkaline phosphatase ≤ 5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No New York Heart Association class III or IV congestive heart failure\n* No QTc \\> 450 msec for males or \\> 470 msec for females\n* No personal or family history of congenital long QT syndrome\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n* No pre-existing neuropathy grade 2 or greater\n* No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor\n* No infection requiring parenteral or oral anti-infective treatment\n* No altered mental status or psychiatric condition that would preclude giving informed consent\n* No other medical condition that would preclude study participation\n* No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen \\< 2 ng/mL\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent sargramostim (GM-CSF)\n* No concurrent routine prophylactic use of filgrastim (G-CSF)\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior chemotherapy and recovered\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* At least 3 weeks since prior surgery and recovered\n\nOther\n\n* More than 3 weeks since prior investigational agents (therapeutic or diagnostic)\n* No other concurrent therapy for advanced or metastatic colorectal cancer\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00077259', 'briefTitle': 'Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)', 'orgStudyIdInfo': {'id': '03-113'}, 'secondaryIdInfos': [{'id': 'MSKCC-03113'}, {'id': 'ROCHE-NO17320'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'epothilone D', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Leonard B. Saltz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}