NCT00023777

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00023777

Principal Investigator:

Study Type:

INTERVENTIONAL

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: filgrastim
- Description: induction: 5 mcg/kg/d IV or SC starting apx day 15
- Arm Group Labels:
- Type: BIOLOGICAL
- Name: sargramostim
- Description: induction: 250 mcg/m2/d IV or SC starting apx day 1
- Arm Group Labels:
- Type: DRUG
- Name: cytarabine
- Description: ind: 200 mg/m2/d continuous IV days 1-7 consol: 200 mg/m2/d continuous IV days 1-5
- Arm Group Labels:
- Type: DRUG
- Name: daunorubicin hydrochloride
- Description: ind and consol: 45 mg/m2/d continuous IV days 1-3
- Arm Group Labels:

Sponsor

SWOG Cancer Research Network