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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine; Daunorubicin; Sargramostim

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:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified