drugset / Trial / NCT00005823

Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT00005823

Phase 3 Completed 2000 enrolled Leukemia Research Fund
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy. PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.

Timeline

Start
1998-12
Primary completion
Completion
2007-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 200 mg/m2 Intravenous
Subject Cytarabine Small molecule 400 mg/m2 Intravenous
Subject Daunorubicin Small molecule 35 mg/m2 Intravenous
Subject Daunorubicin Small molecule 50 mg/m2 Intravenous
Subject Etoposide Small molecule Intravenous
Subject Hydroxyurea Other / unclassified Oral
Subject Idarubicin Small molecule Intravenous
Subject Mitoxantrone Small molecule Intravenous
Subject Thioguanine Small molecule Oral
Subject Tretinoin Small molecule Oral
Subject valspodar Protein / enzyme biologic