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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
First received: September 13, 2001
Last updated: March 5, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Biological: filgrastim
Biological: sargramostim
Drug: cytarabine
Drug: daunorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • CR [ Time Frame: After induction therapy is completed ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: August 2001
Study Completion Date: April 2008
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:


  • 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.


Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00023777

  Show 98 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Thomas R. Chauncey, MD, PhD University of Washington
  More Information

Additional Information:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00023777     History of Changes
Other Study ID Numbers: S0112, S0112, U10CA032102
Study First Received: September 13, 2001
Last Updated: March 5, 2015
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
untreated adult acute myeloid leukemia
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute eosinophilic leukemia
adult acute basophilic leukemia
adult acute megakaryoblastic leukemia (M7)
adult acute monocytic leukemia (M5b)
adult acute minimally differentiated myeloid leukemia (M0)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2015