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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted56 and overNCI, OtherS0112
U10CA032102, SWOG-S0112, NCT00023777

Trial Description


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.

Further Study Information


  • 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.

Eligibility Criteria


  • 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



  • 56 and over

Performance status:

  • Zubrod 0-3

Life expectancy:

  • Not specified


  • Not specified


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


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


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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • Not specified


  • Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

  • National Cancer Institute
Thomas R. Chauncey, Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00023777
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.