Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 8:37 PM
Study NCT ID:
NCT00021268
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tocladesine in Treating Patients With Recurrent or Progressive 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': 'C044258', 'term': '8-chloro-cyclic adenosine monophosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-10', 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-09-09', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer'], '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 I trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer.\n* Determine the qualitative and quantitative toxicity of this drug in these patients.\n* Assess any therapeutic activity in patients treated with this drug.\n\nOUTLINE: This is a dose-escalation, multicenter study.\n\nPatients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional patients are treated at this dose level.\n\nPROJECTED ACCRUAL: A total of 3-38 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of metastatic carcinoma of the colon or rectum\n\n * Recurrent or progressive after failing prior fluorouracil and irinotecan chemotherapy, sequentially or in combination, unless unable to tolerate irinotecan\n* Measurable disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 75\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST and ALT no greater than 5 times ULN\n* PT/aPTT no greater than 1.2 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n* Creatinine clearance at least 50 mL/min\n* No impaired renal function\n\nCardiovascular:\n\n* No impaired cardiac function\n\nOther:\n\n* No active infection\n* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No other concurrent anticancer drugs\n* No concurrent chronic non-steroidal anti-inflammatory agents\n* No concurrent chronic therapeutic anticoagulation'}, 'identificationModule': {'nctId': 'NCT00021268', 'briefTitle': 'Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan', 'orgStudyIdInfo': {'id': 'ICN-2000-1'}, 'secondaryIdInfos': [{'id': 'UCLA-0006008'}, {'id': 'CDR0000068764', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-G01-1979'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'tocladesine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Lee S. Rosen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}