Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00040820
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2002-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or 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': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-03', 'studyFirstSubmitDate': '2002-07-08', 'studyFirstSubmitQcDate': '2003-07-07', 'lastUpdatePostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, '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.\n\nPURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.', 'detailedDescription': 'OBJECTIVES:\n\n* Provide oxaliplatin for patients with previously treated locally advanced or metastatic colorectal cancer who have exhausted all approved therapies for colorectal cancer.\n\nOUTLINE: This is a multicenter, Treatment Access Program study.\n\nPatients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for at least 30 days.\n\nPROJECTED ACCRUAL: Approximately one patient per site per month 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 adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy\n\n * Locally advanced OR\n * Metastatic disease\n* Patients who progressed on a non-oxaliplatin-containing (control) arm in Sanofi-Synthelabo second-line regulatory trials OR\n* Patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens\n* Documented radiological disease progression after last anticancer treatment\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 75,000/mm3\n\nHepatic:\n\n* SGOT or SGPT no greater than 6 times upper limit of normal (ULN)\n* Bilirubin no greater than 2 mg/dL\n* Alkaline phosphatase no greater than 5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study\n* Adequate organ function and medically stable\n* No known concurrent peripheral neuropathy\n* Absence of deep tendon reflexes as the sole neurologic abnormality is allowed\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 30 days since prior chemotherapy\n* No prior oxaliplatin-based chemotherapy\n* No other concurrent investigational chemotherapy agents\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 30 days since prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* At least 30 days since prior major surgical procedure or intervention\n\nOther:\n\n* At least 30 days since other prior anticancer therapy\n* No other concurrent anticancer agents\n* No concurrent participation in any other investigational studies'}, 'identificationModule': {'nctId': 'NCT00040820', 'briefTitle': 'Oxaliplatin in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'CDR0000069410'}, 'secondaryIdInfos': [{'id': 'RPCI-DS-0130'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Milind Javle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Miland Javle, MD', 'oldOrganization': 'Roswell Park Cancer Institute'}}}}