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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00023777
Collaborator
National Cancer Institute (NCI) (NIH)
71
Enrollment
98
Locations
80
Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: filgrastim
  • Biological: sargramostim
  • Drug: cytarabine
  • Drug: daunorubicin hydrochloride
 Phase 2

Detailed Description

OBJECTIVES:

  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Aug 1, 2001
Actual Primary Completion Date :
Jun 1, 2003
Actual Study Completion Date :
Apr 1, 2008

Outcome Measures

Primary Outcome Measures

  1. CR [After induction therapy is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:
56 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
3 Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix Arizona United States 85012
4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
5 Arizona Cancer Center Tucson Arizona United States 85724
6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
8 City of Hope Comprehensive Cancer Center Duarte California United States 91010
9 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
10 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
11 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
14 Chao Family Comprehensive Cancer Center Orange California United States 92868
15 University of California Davis Medical Center Sacramento California United States 95817
16 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
17 David Grant Medical Center Travis Air Force Base California United States 94535
18 University of Colorado Cancer Center Denver Colorado United States 80010
19 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
20 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
21 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
22 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
23 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813-2424
24 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
25 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
26 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
27 CCOP - Central Illinois Decatur Illinois United States 62526
28 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
29 Loyola University Medical Center Maywood Illinois United States 60153-5500
30 University of Kansas Medical Center Kansas City Kansas United States 66160-7353
31 CCOP - Wichita Wichita Kansas United States 67214-3882
32 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
33 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40502-2236
34 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
35 MBCCOP - LSU Medical Center New Orleans Louisiana United States 70112
36 Tulane University School of Medicine New Orleans Louisiana United States 70112
37 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
38 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
39 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
40 Boston Medical Center Boston Massachusetts United States 02118
41 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
42 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
43 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
44 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0912
45 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
46 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
47 Henry Ford Hospital Detroit Michigan United States 48202
48 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
49 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
50 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
51 CCOP - Duluth Duluth Minnesota United States 55805
52 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
53 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
54 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
55 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
56 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
57 CCOP - Kansas City Kansas City Missouri United States 64131
58 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110
59 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
60 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
61 CCOP - Montana Cancer Consortium Billings Montana United States 59101
62 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
63 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
64 Veterans Affairs Medical Center - Albany Albany New York United States 12208
65 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
66 University of Rochester Medical Center Rochester New York United States 14642
67 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
68 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
69 Barrett Cancer Center Cincinnati Ohio United States 45267-0501
70 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195-9001
71 CCOP - Columbus Columbus Ohio United States 43206
72 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
73 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
74 CCOP - Dayton Kettering Ohio United States 45429
75 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
76 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
77 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
78 CCOP - Columbia River Program Portland Oregon United States 97225
79 Oregon Cancer Institute Portland Oregon United States 97239
80 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
81 Medical University of South Carolina Charleston South Carolina United States 29425-0721
82 CCOP - Greenville Greenville South Carolina United States 29615
83 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
84 Brooke Army Medical Center Fort Sam Houston Texas United States 78234-6200
85 University of Texas Medical Branch Galveston Texas United States 77555-0565
86 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
87 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7845
88 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
89 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
90 CCOP - Scott and White Hospital Temple Texas United States 76508
91 Huntsman Cancer Institute Salt Lake City Utah United States 84112-5550
92 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
93 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
94 Swedish Cancer Institute Seattle Washington United States 98104
95 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
96 University of Washington School of Medicine Seattle Washington United States 98195
97 CCOP - Northwest Tacoma Washington United States 98405-0986
98 Madigan Army Medical Center Tacoma Washington United States 98431-5000

Sponsors and Collaborators

  • Southwest Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Thomas R. Chauncey, MD, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00023777
Other Study ID Numbers:
  • S0112
  • S0112
  • U10CA032102
First Posted:
Jan 27, 2003
Last Update Posted:
Mar 6, 2015
Last Verified:
Mar 1, 2015
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
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Daunorubicin
Sargramostim

Study Results

No Results Posted as of Mar 6, 2015