{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"16"}],"units":"Participants"}],"description":"DLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity.","groups":[{"description":"Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles","id":"OG000","title":"Dose Level 1"},{"description":"Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles","id":"OG001","title":"Dose Level 2"},{"description":"Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles","id":"OG002","title":"Dose Level 3"},{"description":"Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles","id":"OG003","title":"Dose Level 4"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"up to 7 weeks","title":"Number of Patients With Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"patients"}