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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023777 |
Purpose
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 |
|
Leukemia |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: filgrastim Drug: sargramostim |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Filgrastim Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Sargramostim Granulocyte-macrophage colony-stimulating factor |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | August 2001 |
OBJECTIVES:
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
| Ages Eligible for Study: | 56 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations![]() |
Show 98 Study Locations |
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Thomas R. Chauncey, MD, PhD | University of Washington |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068861, SWOG-S0112 |
| First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00023777 |
| Health Authority: | United States: Federal Government |
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