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

NCT00023777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2015-03-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Thomas R. Chauncey, MD, PhD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
56 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2003-06-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00023777 on ClinicalTrials.gov