Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 9:36 PM
Study NCT ID:
NCT00004059
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C054852', 'term': '7-hydroxystaurosporine'}, {'id': 'D005472', 'term': 'Fluorouracil'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-05-07', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.\n\nPURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose, dose limiting toxicity, and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors.\n* Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients.\n* Obtain preliminary data on the therapeutic activity of this regimen in these patients.\n\nOUTLINE: This is a dose escalation study of fluorouracil.\n\nPatients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of fluorouracil 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.\n\nPROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study within approximately 14 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists\n* Measurable or evaluable disease\n* No CNS metastasis or primary CNS malignancy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,500/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT and SGPT no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular:\n\n* No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting\n* No cardiac arrhythmias or congestive heart failure within the past 6 months\n* Stable atrial fibrillation on standard treatment allowed at discretion of investigator\n\nPulmonary:\n\n* DLCO at least 60% of predicted\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after study\n* No active serious or uncontrolled infection\n* HIV negative\n* No diabetes\n* No other medical condition that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy and recovered\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered\n* Prior fluorouracil allowed\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior mediastinal radiotherapy\n* At least 4 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent anticonvulsant medications'}, 'identificationModule': {'nctId': 'NCT00004059', 'briefTitle': 'Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase I Study of the Cyclin-Dependent Kinase (CDK)/Protein Kinase C (PKC) Inhibitor UCN-01 (NSC 638850) in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '99-024'}, 'secondaryIdInfos': [{'id': 'CDR0000067256', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-T99-0037'}]}, 'armsInterventionsModule': {'interventions': [{'name': '7-hydroxystaurosporine', 'type': 'DRUG'}, {'name': 'fluorouracil', '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': 'Gary K. Schwartz, 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'}]}}}