NCT00023777

S0112 Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia

A Phase II Study Of Daunomycin And ARA-C, Both Given By Continous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 56 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated.

Detailed description

OBJECTIVES: * Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in older patients with previously untreated non-M3 acute myeloid leukemia. * Determine the frequency and severity of toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7. Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover. Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5. Beginning no earlier than day 19, patients receive a second course of consolidation chemotherapy. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: Approximately 30-55 patients will be accrued for this study within 8-9 months.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	induction: 5 mcg/kg/d IV or SC starting apx day 15
BIOLOGICAL	sargramostim	induction: 250 mcg/m2/d IV or SC starting apx day 1
DRUG	cytarabine	ind: 200 mg/m2/d continuous IV days 1-7 consol: 200 mg/m2/d continuous IV days 1-5
DRUG	daunorubicin hydrochloride	ind and consol: 45 mg/m2/d continuous IV days 1-3

Timeline

• Start date: 2001-08-01
• Primary completion: 2003-06-01
• Completion: 2008-04-01
• First posted: 2003-01-27
• Last updated: 2015-03-06

Locations

98 sites across 1 country: United States