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

SWOG Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Leukemia

Treatments

Biological: filgrastim

Drug: cytarabine

Drug: daunorubicin hydrochloride

Biological: sargramostim

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00023777

S0112 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

All

Ages

56+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed acute myeloid leukemia (AML)
- No M3 AML or blastic transformation of chronic myelogenous leukemia
Must be enrolled on SWOG-9007 and S9910 protocols

PATIENT CHARACTERISTICS:

Age:

56 and over

Performance status:

Zubrod 0-3

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 2 times upper limit of normal (ULN)
SGOT or SGPT no greater than 4 times ULN

Renal:

Creatinine no greater than 1.5 times ULN OR
Creatinine clearance greater than 40 mL/min

Cardiovascular:

LVEF at least 50% by MUGA scan or 2-dimensional echocardiogram
No unstable cardiac arrhythmias
No unstable angina

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior systemic chemotherapy for acute leukemia
Prior hydroxyurea to control high cell counts allowed
Prior low-dose cytarabine (less than 100 mg/m^2/day) for treatment of myelodysplastic syndrome allowed
At least 30 days since prior chemotherapy and recovered
Concurrent single-dose intrathecal chemotherapy allowed

Endocrine therapy: