Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00658814
Collaborator
(none)
133
178
1
0.7

Study Details

Study Description

Brief Summary

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES:
  1. To test whether outcomes of patients of age 60 or older with previously untreated non-M3 acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to warrant phase III investigation.

  2. To estimate the frequency and severity of toxicities of this regimen in the good- and poor-risk groups of patients.

  3. To investigate in a preliminary manner the disease-free survival of patients who achieve complete remission and receive post-remission therapy on this study.

  4. To investigate in a preliminary manner the cytogenetic response rates of patients treated with this regimen.

  5. To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter and global methylation changes, and multidrug resistance on overall survival and response to azacitidine plus gemtuzumab ozogamicin therapy.

OUTLINE: Patients are stratified according to risk status (good [60-69 years of age OR Zubrod performance status [PS] 0-1] vs poor [>= 70 years of age AND Zubrod PS 2-3]).

REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily (QD) on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients with residual leukemia (blast count >= 5%) receive a second course of induction therapy beginning between days 15-29. Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.

CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin as in induction therapy (with azacitidine given SC only).

MAINTENANCE THERAPY: Patients receive azacitidine SC on days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic studies at baseline, remission, and relapse or progression (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) Repository in Seattle, WA.

After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia
Actual Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (azacitidine, gemtuzumab)

See Detailed Description

Drug: Azacitidine
Given IV or SC during induction; given SC during consolidation and maintenance
Other Names:
  • 5 AZC
  • 5-AC
  • 5-Azacytidine
  • 5-AZC
  • Azacytidine
  • Azacytidine, 5-
  • Ladakamycin
  • Mylosar
  • Onureg
  • U-18496
  • Vidaza
  • Drug: Gemtuzumab Ozogamicin
    Given IV
    Other Names:
  • Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody
  • CDP-771
  • CMA-676
  • gemtuzumab
  • hP67.6-Calicheamicin
  • Mylotarg
  • WAY-CMA-676
  • Outcome Measures

    Primary Outcome Measures

    1. Complete Response [Up to 60 days]

      Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.

    2. 30-Day Survival [30 days]

      Patients surviving more than 30 days after study registration

    Secondary Outcome Measures

    1. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [Up to 5 years]

      Only adverse events that are possibly, probably or definitely related to study drug are reported.

    2. Relapse-free Survival [Up to 5 years]

      Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible

    • Zubrod performance status 0-3

    • No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin

    • No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted

    • Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:

    • No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support

    • Prior cytarabine allowed if dose < 100 mg/m^2/day

    • Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed

    • No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin

    • At least 30 days since prior therapy for MDS and recovered

    • Bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML

    • Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed

    • Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML

    • Serum creatinine =< 1.5 x IULN

    • Left ventricle ejection fraction (LVEF) >= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days

    • Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory

    • Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking

    • No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture

    • Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method

    • Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration

    • HIV-positive patients must meet the following criteria:

    • No history of acquired immunodeficiency syndrome (AIDS)-defining events

    • CD4 cells >= 500/mm^3

    • Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on cART or < 25,000 copies HIV mRNA if not on cART

    • No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study

    • No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed

    • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

    • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

    • Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration

    • Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) >= 1,000/mcL and platelets >= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration

    • Patients must have serum creatinine =< 1.5 x IULN and SGOT or SGPT =< 1.5 x IULN within 28 days before registration

    • Patients must have recovered to =< Grade 2 from any induction cycle non-hematologic toxicities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    2 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    3 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    4 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    5 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    6 Saint Anthony's Health Alton Illinois United States 62002
    7 Decatur Memorial Hospital Decatur Illinois United States 62526
    8 Heartland Cancer Research NCORP Decatur Illinois United States 62526
    9 Advocate Sherman Hospital Elgin Illinois United States 60123
    10 Loyola University Medical Center Maywood Illinois United States 60153
    11 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    12 Memorial Medical Center Springfield Illinois United States 62781
    13 Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana United States 46107
    14 Reid Health Richmond Indiana United States 47374
    15 Hospital District Sixth of Harper County Anthony Kansas United States 67003
    16 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    17 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    18 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    19 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    20 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    21 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    22 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    23 Southwest Medical Center Liberal Kansas United States 67901
    24 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    25 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    26 Menorah Medical Center Overland Park Kansas United States 66209
    27 Saint Luke's South Hospital Overland Park Kansas United States 66213
    28 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    29 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
    30 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    31 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    32 Salina Regional Health Center Salina Kansas United States 67401
    33 Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
    34 Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas United States 66606
    35 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    36 Associates In Womens Health Wichita Kansas United States 67208
    37 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    38 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    39 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    40 Wesley Medical Center Wichita Kansas United States 67214
    41 Wichita NCI Community Oncology Research Program Wichita Kansas United States 67214
    42 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    43 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    44 Hematology/Oncology Clinic PLLC Baton Rouge Louisiana United States 70809
    45 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    46 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    47 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    48 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    49 Bronson Battle Creek Battle Creek Michigan United States 49017
    50 Spectrum Health Big Rapids Hospital Big Rapids Michigan United States 49307
    51 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    52 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    53 Ascension Saint John Hospital Detroit Michigan United States 48236
    54 Hurley Medical Center Flint Michigan United States 48503
    55 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    56 Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan United States 49503
    57 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    58 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    59 Allegiance Health Jackson Michigan United States 49201
    60 Sparrow Hospital Lansing Michigan United States 48912
    61 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    62 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    63 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    64 Lake Huron Medical Center Port Huron Michigan United States 48060
    65 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    66 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    67 Munson Medical Center Traverse City Michigan United States 49684
    68 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    69 Metro Health Hospital Wyoming Michigan United States 49519
    70 University of Mississippi Medical Center Jackson Mississippi United States 39216
    71 Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    72 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    73 Truman Medical Centers Kansas City Missouri United States 64108
    74 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    75 Saint Joseph Health Center Kansas City Missouri United States 64114
    76 North Kansas City Hospital Kansas City Missouri United States 64116
    77 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    78 Research Medical Center Kansas City Missouri United States 64132
    79 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    80 Liberty Radiation Oncology Center Liberty Missouri United States 64068
    81 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    82 Saint Joseph Oncology Inc Saint Joseph Missouri United States 64507
    83 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    84 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    85 Saint Louis-Cape Girardeau CCOP Saint Louis Missouri United States 63141
    86 Billings Clinic Cancer Center Billings Montana United States 59101
    87 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    88 Saint Vincent Healthcare Billings Montana United States 59101
    89 Montana Cancer Consortium NCORP Billings Montana United States 59102
    90 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    91 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    92 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    93 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    94 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    95 Great Falls Clinic Great Falls Montana United States 59405
    96 Northern Montana Hospital Havre Montana United States 59501
    97 Saint Peter's Community Hospital Helena Montana United States 59601
    98 Glacier Oncology PLLC Kalispell Montana United States 59901
    99 Kalispell Medical Oncology Kalispell Montana United States 59901
    100 Kalispell Regional Medical Center Kalispell Montana United States 59901
    101 Montana Cancer Specialists Missoula Montana United States 59802
    102 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    103 Community Medical Hospital Missoula Montana United States 59804
    104 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    105 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    106 University of Rochester Rochester New York United States 14642
    107 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    108 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    109 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    110 Rutherford Hospital Rutherfordton North Carolina United States 28139
    111 Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina United States 27104
    112 Cleveland Clinic Akron General Akron Ohio United States 44307
    113 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    114 Adena Regional Medical Center Chillicothe Ohio United States 45601
    115 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    116 Riverside Methodist Hospital Columbus Ohio United States 43214
    117 Columbus NCI Community Oncology Research Program Columbus Ohio United States 43215
    118 Grant Medical Center Columbus Ohio United States 43215
    119 Mount Carmel Health Center West Columbus Ohio United States 43222
    120 Doctors Hospital Columbus Ohio United States 43228
    121 Grandview Hospital Dayton Ohio United States 45405
    122 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    123 Miami Valley Hospital Dayton Ohio United States 45409
    124 Miami Valley Hospital North Dayton Ohio United States 45415
    125 Dayton NCI Community Oncology Research Program Dayton Ohio United States 45459
    126 Grady Memorial Hospital Delaware Ohio United States 43015
    127 Blanchard Valley Hospital Findlay Ohio United States 45840
    128 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    129 Wayne Hospital Greenville Ohio United States 45331
    130 Kettering Medical Center Kettering Ohio United States 45429
    131 Fairfield Medical Center Lancaster Ohio United States 43130
    132 Marietta Memorial Hospital Marietta Ohio United States 45750
    133 Knox Community Hospital Mount Vernon Ohio United States 43050
    134 Licking Memorial Hospital Newark Ohio United States 43055
    135 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    136 Springfield Regional Medical Center Springfield Ohio United States 45505
    137 Upper Valley Medical Center Troy Ohio United States 45373
    138 Saint Ann's Hospital Westerville Ohio United States 43081
    139 Clinton Memorial Hospital Wilmington Ohio United States 45177
    140 Greene Memorial Hospital Xenia Ohio United States 45385
    141 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    142 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    143 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    144 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    145 Providence Newberg Medical Center Newberg Oregon United States 97132
    146 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
    147 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    148 Providence Portland Medical Center Portland Oregon United States 97213
    149 Adventist Medical Center Portland Oregon United States 97216
    150 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    151 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    152 Salem Hospital Salem Oregon United States 97301
    153 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    154 AnMed Health Hospital Anderson South Carolina United States 29621
    155 Medical University of South Carolina Charleston South Carolina United States 29425
    156 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    157 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    158 Cancer Care Center at Island Hospital Anacortes Washington United States 98221
    159 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    160 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    161 Highline Medical Center-Main Campus Burien Washington United States 98166
    162 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    163 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    164 Skagit Valley Hospital Mount Vernon Washington United States 98274
    165 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    166 Harborview Medical Center Seattle Washington United States 98104
    167 Minor and James Medical PLLC Seattle Washington United States 98104
    168 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    169 Kaiser Permanente Washington Seattle Washington United States 98112
    170 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    171 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    172 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    173 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    174 Evergreen Hematology and Oncology PS Spokane Washington United States 99218
    175 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    176 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
    177 Rocky Mountain Oncology Casper Wyoming United States 82609
    178 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Sucha Nand, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00658814
    Other Study ID Numbers:
    • NCI-2009-00790
    • NCI-2009-00790
    • SWOG-S0703
    • CDR0000593117
    • S0703
    • S0703
    • U10CA032102
    First Posted:
    Apr 15, 2008
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
    Arm/Group Description Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients in continued remission may go on to receive maintenance therapy. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients in continued remission may go on to receive maintenance therapy. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
    Period Title: Remission Induction Chemotherapy
    STARTED 83 59
    Eligible 82 57
    Eligible and Began Protocol Therapy 79 54
    COMPLETED 75 41
    NOT COMPLETED 8 18
    Period Title: Remission Induction Chemotherapy
    STARTED 24 13
    Eligible 22 11
    COMPLETED 22 10
    NOT COMPLETED 2 3
    Period Title: Remission Induction Chemotherapy
    STARTED 20 8
    Eligible 19 8
    COMPLETED 17 7
    NOT COMPLETED 3 1

    Baseline Characteristics

    Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Total
    Arm/Group Description Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) Total of all reporting groups
    Overall Participants 79 54 133
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    71.2
    76
    73.4
    Sex: Female, Male (Count of Participants)
    Female
    30
    38%
    21
    38.9%
    51
    38.3%
    Male
    49
    62%
    33
    61.1%
    82
    61.7%
    Race/Ethnicity, Customized (participants) [Number]
    Asian
    1
    1.3%
    0
    0%
    1
    0.8%
    Black or African American
    1
    1.3%
    4
    7.4%
    5
    3.8%
    White
    77
    97.5%
    50
    92.6%
    127
    95.5%
    Hispanic (participants) [Number]
    Yes
    3
    3.8%
    1
    1.9%
    4
    3%
    No
    64
    81%
    50
    92.6%
    114
    85.7%
    Unknown
    12
    15.2%
    3
    5.6%
    15
    11.3%

    Outcome Measures

    1. Secondary Outcome
    Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
    Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
    Arm/Group Title Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
    Arm/Group Description Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
    Measure Participants 133 32 27
    ALT, SGPT (serum glutamic pyruvic transaminase)
    5
    6.3%
    0
    0%
    0
    0%
    AST, SGOT
    4
    5.1%
    0
    0%
    0
    0%
    Adult respiratory distress syndrome (ARDS)
    1
    1.3%
    0
    0%
    0
    0%
    Albumin, serum-low (hypoalbuminemia)
    5
    6.3%
    1
    1.9%
    0
    0%
    Anorexia
    5
    6.3%
    1
    1.9%
    0
    0%
    Bilirubin (hyperbilirubinemia)
    3
    3.8%
    0
    0%
    0
    0%
    Calcium, serum-low (hypocalcemia)
    6
    7.6%
    0
    0%
    0
    0%
    Carbon monoxide diffusion capacity (DL(co))
    1
    1.3%
    0
    0%
    0
    0%
    Cardiac Arrhythmia-Atrial fibrilation
    1
    1.3%
    0
    0%
    0
    0%
    Cardiac General-cardiopulmonary disease
    1
    1.3%
    0
    0%
    0
    0%
    Cardiac General-Chest Pain
    1
    1.3%
    0
    0%
    0
    0%
    Cardiac troponin I (cTnI)
    1
    1.3%
    0
    0%
    0
    0%
    Cardiac-ischemia/infarction
    1
    1.3%
    0
    0%
    0
    0%
    Conduction abnormality NOS
    1
    1.3%
    0
    0%
    0
    0%
    Confusion
    1
    1.3%
    0
    0%
    0
    0%
    Constipation
    2
    2.5%
    0
    0%
    0
    0%
    Cytokine release syndrome/acute infusion reaction
    1
    1.3%
    0
    0%
    0
    0%
    Death - Disease progression NOS
    1
    1.3%
    0
    0%
    0
    0%
    Death - Multi-organ failure
    2
    2.5%
    0
    0%
    0
    0%
    Death not associated with CTCAE term - Death NOS
    1
    1.3%
    0
    0%
    0
    0%
    Dehydration
    1
    1.3%
    0
    0%
    0
    0%
    Diarrhea
    2
    2.5%
    0
    0%
    0
    0%
    Dyspnea (shortness of breath)
    5
    6.3%
    1
    1.9%
    2
    1.5%
    Edema: limb
    1
    1.3%
    0
    0%
    0
    0%
    Fatigue (asthenia, lethargy, malaise)
    18
    22.8%
    1
    1.9%
    1
    0.8%
    Febrile neutropenia
    50
    63.3%
    0
    0%
    0
    0%
    Glucose, serum-high (hyperglycemia)
    10
    12.7%
    3
    5.6%
    2
    1.5%
    Hemoglobin
    73
    92.4%
    1
    1.9%
    1
    0.8%
    Hemorrhage, CNS
    1
    1.3%
    0
    0%
    0
    0%
    Hemorrhage, GI - Stomach
    1
    1.3%
    0
    0%
    0
    0%
    Hemorrhage, GI - Upper GI NOS
    1
    1.3%
    0
    0%
    0
    0%
    Hemorrhage/Bleeding-platelets and red blood cells
    1
    1.3%
    0
    0%
    0
    0%
    Hepatobiliary/Pancreas-venoocclusive disease
    1
    1.3%
    0
    0%
    0
    0%
    Hypertension
    1
    1.3%
    0
    0%
    0
    0%
    Hypotension
    2
    2.5%
    0
    0%
    0
    0%
    Hypoxia
    4
    5.1%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Blood
    16
    20.3%
    0
    0%
    1
    0.8%
    Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
    2
    2.5%
    1
    1.9%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Colon
    1
    1.3%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva
    1
    1.3%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth
    3
    3.8%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Kidney
    1
    1.3%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung
    8
    10.1%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
    1
    1.3%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
    2
    2.5%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - Skin
    6
    7.6%
    0
    0%
    0
    0%
    Inf (clin/microbio) w/Gr 3-4 neuts - UTI
    3
    3.8%
    0
    0%
    0
    0%
    Inf w/normal ANC or Gr 1-2 neutrophils - Blood
    2
    2.5%
    1
    1.9%
    0
    0%
    Inf w/normal ANC or Gr 1-2 neutrophils - Lung
    0
    0%
    0
    0%
    1
    0.8%
    Inf w/normal ANC or Gr 1-2 neutrophils - Skin
    1
    1.3%
    0
    0%
    0
    0%
    Infection with unknown ANC - Blood
    1
    1.3%
    0
    0%
    0
    0%
    Infection with unknown ANC - Lung (pneumonia)
    1
    1.3%
    0
    0%
    0
    0%
    Infection with unknown ANC - Skin (cellulitis)
    1
    1.3%
    0
    0%
    0
    0%
    Infection-Aspirgillosis
    1
    1.3%
    0
    0%
    0
    0%
    Infection-bacteremia
    1
    1.3%
    0
    0%
    0
    0%
    Left ventricular systolic dysfunction
    1
    1.3%
    0
    0%
    0
    0%
    Leukocytes (total WBC)
    80
    101.3%
    18
    33.3%
    6
    4.5%
    Liver dysfunction/failure (clinical)
    0
    0%
    1
    1.9%
    0
    0%
    Lymphopenia
    23
    29.1%
    0
    0%
    1
    0.8%
    Mood alteration - depression
    2
    2.5%
    0
    0%
    0
    0%
    Mucositis/stomatitis (functional/symp) - Oral cav
    1
    1.3%
    0
    0%
    0
    0%
    Muscle weakness, not d/t neuropathy - body/general
    4
    5.1%
    0
    0%
    0
    0%
    Neutrophils/granulocytes (ANC/AGC)
    85
    107.6%
    21
    38.9%
    10
    7.5%
    Pain - Cardiac/heart
    2
    2.5%
    0
    0%
    0
    0%
    Petechiae/purpura (hemorrhage into skin or mucosa)
    1
    1.3%
    0
    0%
    0
    0%
    Phosphate, serum-low (hypophosphatemia)
    4
    5.1%
    0
    0%
    0
    0%
    Platelets
    85
    107.6%
    12
    22.2%
    3
    2.3%
    Pleural effusion (non-malignant)
    1
    1.3%
    0
    0%
    0
    0%
    Pneumonitis/pulmonary infiltrates
    1
    1.3%
    0
    0%
    0
    0%
    Potassium, serum-low (hypokalemia)
    5
    6.3%
    0
    0%
    0
    0%
    Pulmonary/Upper Respiratory-pulmonary edema
    2
    2.5%
    0
    0%
    0
    0%
    Rash/desquamation
    1
    1.3%
    0
    0%
    0
    0%
    SVT and nodal arrhythmia - Atrial fibrillation
    2
    2.5%
    0
    0%
    0
    0%
    SVT and nodal arrhythmia - SVT tachycardia
    1
    1.3%
    0
    0%
    0
    0%
    Sodium, serum-low (hyponatremia)
    5
    6.3%
    0
    0%
    0
    0%
    Sudden death
    1
    1.3%
    0
    0%
    0
    0%
    Thrombosis/thrombus/embolism
    2
    2.5%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Complete Response
    Description Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.
    Time Frame Up to 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
    Arm/Group Description Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
    Measure Participants 79 54
    Number (95% Confidence Interval) [percentage of participants]
    44
    55.7%
    35
    64.8%
    3. Primary Outcome
    Title 30-Day Survival
    Description Patients surviving more than 30 days after study registration
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
    Arm/Group Description Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
    Measure Participants 79 54
    Number (95% Confidence Interval) [percentage of participants]
    92
    116.5%
    87
    161.1%
    4. Secondary Outcome
    Title Relapse-free Survival
    Description Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
    Arm/Group Description Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
    Measure Participants 35 19
    Median (95% Confidence Interval) [months]
    8
    7

    Adverse Events

    Time Frame Up to 5 years
    Adverse Event Reporting Description
    Arm/Group Title Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
    Arm/Group Description Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
    All Cause Mortality
    Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 55/133 (41.4%) 1/32 (3.1%) 3/27 (11.1%)
    Blood and lymphatic system disorders
    Febrile neutropenia 10/133 (7.5%) 0/32 (0%) 0/27 (0%)
    Hemoglobin 4/133 (3%) 0/32 (0%) 0/27 (0%)
    Cardiac disorders
    Cardiac-ischemia/infarction 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Conduction abnormality NOS 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Left ventricular systolic dysfunction 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Pain - Cardiac/heart 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    SVT and nodal arrhythmia - Atrial fibrillation 3/133 (2.3%) 0/32 (0%) 0/27 (0%)
    SVT and nodal arrhythmia - SVT tachycardia 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    SVT and nodal arrhythmia - Sinus tachycardia 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Ventricular arrhythmia - Ventricular fibrillation 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Gastrointestinal disorders
    Colitis 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Hemorrhage, GI - Stomach 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Hemorrhage, GI - Upper GI NOS 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Ileus, GI (functional obstruction of bowel) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Obstruction, GI - Small bowel NOS 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    General disorders
    Death - Multi-organ failure 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Death not associated with CTCAE term - Death NOS 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Fatigue (asthenia, lethargy, malaise) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Sudden death 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Hepatobiliary disorders
    Liver dysfunction/failure (clinical) 0/133 (0%) 1/32 (3.1%) 0/27 (0%)
    Immune system disorders
    Cytokine release syndrome/acute infusion reaction 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Infections and infestations
    Inf (clin/microbio) w/Gr 3-4 neuts - Blood 7/133 (5.3%) 0/32 (0%) 0/27 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel 1/133 (0.8%) 1/32 (3.1%) 0/27 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung 7/133 (5.3%) 0/32 (0%) 0/27 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Sinus 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Skin 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Inf w/normal ANC or Gr 1-2 neutrophils - Blood 3/133 (2.3%) 0/32 (0%) 0/27 (0%)
    Inf w/normal ANC or Gr 1-2 neutrophils - Lung 0/133 (0%) 0/32 (0%) 1/27 (3.7%)
    Infection with unknown ANC - Blood 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Infection with unknown ANC - Lung (pneumonia) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Infection-Other (Specify):bacteremia 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Injury, poisoning and procedural complications
    Fracture 0/133 (0%) 0/32 (0%) 1/27 (3.7%)
    Hemorrhage/bleeding w/surgery, intra- or post-op 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    AST, SGOT 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Bilirubin (hyperbilirubinemia) 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Carbon monoxide diffusion capacity (DL(co)) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Cardiac troponin I (cTnI) 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Creatinine 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Leukocytes (total WBC) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Neutrophils/granulocytes (ANC/AGC) 3/133 (2.3%) 0/32 (0%) 0/27 (0%)
    Platelets 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Metabolism and nutrition disorders
    Acidosis (metabolic or respiratory) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Albumin, serum-low (hypoalbuminemia) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Calcium, serum-low (hypocalcemia) 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Glucose, serum-high (hyperglycemia) 2/133 (1.5%) 0/32 (0%) 1/27 (3.7%)
    Magnesium, serum-low (hypomagnesemia) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Phosphate, serum-low (hypophosphatemia) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Potassium, serum-high (hyperkalemia) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Tumor lysis syndrome 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle weakness, not d/t neuropathy - body/general 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Pain - Back 0/133 (0%) 0/32 (0%) 1/27 (3.7%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Death - Disease progression NOS 12/133 (9%) 0/32 (0%) 0/27 (0%)
    Myelodysplasia 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Nervous system disorders
    CNS cerebrovascular ischemia 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Encephalopathy 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Hemorrhage, CNS 3/133 (2.3%) 0/32 (0%) 0/27 (0%)
    Neurology-Other 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Psychiatric disorders
    Confusion 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Mood alteration - depression 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Renal and urinary disorders
    Proteinuria 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Renal failure 1/133 (0.8%) 0/32 (0%) 1/27 (3.7%)
    Respiratory, thoracic and mediastinal disorders
    Carbon monoxide diffusion capacity (DL(co)) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Cough 0/133 (0%) 0/32 (0%) 1/27 (3.7%)
    Dyspnea (shortness of breath) 5/133 (3.8%) 0/32 (0%) 1/27 (3.7%)
    Hypoxia 4/133 (3%) 0/32 (0%) 0/27 (0%)
    Pleural effusion (non-malignant) 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Pneumonitis/pulmonary infiltrates 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Pulmonary/Upper Respiratory-Other (Specify):Pulmonary Edema 2/133 (1.5%) 0/32 (0%) 0/27 (0%)
    Pulmonary/Upper Respiratory-Other (Specify):Respiratory distress 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Vascular disorders
    Hypertension 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Hypotension 6/133 (4.5%) 0/32 (0%) 0/27 (0%)
    Thrombosis/thrombus/embolism 3/133 (2.3%) 0/32 (0%) 0/27 (0%)
    Vascular-Other (Specify):pariatal to occiptal lobe 1/133 (0.8%) 0/32 (0%) 0/27 (0%)
    Other (Not Including Serious) Adverse Events
    Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 130/133 (97.7%) 32/32 (100%) 26/27 (96.3%)
    Blood and lymphatic system disorders
    Febrile neutropenia 49/133 (36.8%) 1/32 (3.1%) 0/27 (0%)
    Hemoglobin 98/133 (73.7%) 20/32 (62.5%) 15/27 (55.6%)
    Eye disorders
    Watery eye (epiphora, tearing) 0/133 (0%) 3/32 (9.4%) 0/27 (0%)
    Gastrointestinal disorders
    Constipation 47/133 (35.3%) 6/32 (18.8%) 10/27 (37%)
    Diarrhea 35/133 (26.3%) 1/32 (3.1%) 7/27 (25.9%)
    Heartburn/dyspepsia 8/133 (6%) 1/32 (3.1%) 1/27 (3.7%)
    Hemorrhoids 8/133 (6%) 0/32 (0%) 1/27 (3.7%)
    Mucositis/stomatitis (clinical exam) - Oral cavity 12/133 (9%) 1/32 (3.1%) 1/27 (3.7%)
    Mucositis/stomatitis (functional/symp) - Oral cav 8/133 (6%) 1/32 (3.1%) 0/27 (0%)
    Nausea 56/133 (42.1%) 5/32 (15.6%) 5/27 (18.5%)
    Pain - Abdomen NOS 14/133 (10.5%) 3/32 (9.4%) 2/27 (7.4%)
    Vomiting 27/133 (20.3%) 0/32 (0%) 2/27 (7.4%)
    General disorders
    Edema: limb 30/133 (22.6%) 3/32 (9.4%) 3/27 (11.1%)
    Fatigue (asthenia, lethargy, malaise) 81/133 (60.9%) 15/32 (46.9%) 11/27 (40.7%)
    Fever in absence of neutropenia, ANC lt1.0x10e9/L 14/133 (10.5%) 0/32 (0%) 1/27 (3.7%)
    Injection site reaction/extravasation changes 9/133 (6.8%) 5/32 (15.6%) 9/27 (33.3%)
    Pain - Chest/thorax NOS 7/133 (5.3%) 1/32 (3.1%) 1/27 (3.7%)
    Rigors/chills 21/133 (15.8%) 2/32 (6.3%) 1/27 (3.7%)
    Infections and infestations
    Inf (clin/microbio) w/Gr 3-4 neuts - Blood 15/133 (11.3%) 1/32 (3.1%) 1/27 (3.7%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Skin 9/133 (6.8%) 0/32 (0%) 0/27 (0%)
    Inf w/normal ANC or Gr 1-2 neutrophils - Skin 1/133 (0.8%) 1/32 (3.1%) 2/27 (7.4%)
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 30/133 (22.6%) 5/32 (15.6%) 3/27 (11.1%)
    AST, SGOT 35/133 (26.3%) 10/32 (31.3%) 6/27 (22.2%)
    Alkaline phosphatase 22/133 (16.5%) 4/32 (12.5%) 4/27 (14.8%)
    Bilirubin (hyperbilirubinemia) 18/133 (13.5%) 3/32 (9.4%) 5/27 (18.5%)
    Creatinine 31/133 (23.3%) 6/32 (18.8%) 7/27 (25.9%)
    Leukocytes (total WBC) 87/133 (65.4%) 23/32 (71.9%) 16/27 (59.3%)
    Lymphopenia 40/133 (30.1%) 4/32 (12.5%) 1/27 (3.7%)
    Neutrophils/granulocytes (ANC/AGC) 91/133 (68.4%) 23/32 (71.9%) 14/27 (51.9%)
    Platelets 100/133 (75.2%) 25/32 (78.1%) 11/27 (40.7%)
    Weight loss 13/133 (9.8%) 3/32 (9.4%) 3/27 (11.1%)
    Metabolism and nutrition disorders
    Albumin, serum-low (hypoalbuminemia) 63/133 (47.4%) 13/32 (40.6%) 9/27 (33.3%)
    Anorexia 45/133 (33.8%) 5/32 (15.6%) 5/27 (18.5%)
    Calcium, serum-high (hypercalcemia) 3/133 (2.3%) 3/32 (9.4%) 3/27 (11.1%)
    Calcium, serum-low (hypocalcemia) 45/133 (33.8%) 4/32 (12.5%) 3/27 (11.1%)
    Glucose, serum-high (hyperglycemia) 69/133 (51.9%) 18/32 (56.3%) 19/27 (70.4%)
    Glucose, serum-low (hypoglycemia) 7/133 (5.3%) 2/32 (6.3%) 3/27 (11.1%)
    Magnesium, serum-high (hypermagnesemia) 11/133 (8.3%) 0/32 (0%) 0/27 (0%)
    Magnesium, serum-low (hypomagnesemia) 9/133 (6.8%) 4/32 (12.5%) 2/27 (7.4%)
    Phosphate, serum-low (hypophosphatemia) 19/133 (14.3%) 1/32 (3.1%) 0/27 (0%)
    Potassium, serum-high (hyperkalemia) 7/133 (5.3%) 0/32 (0%) 1/27 (3.7%)
    Potassium, serum-low (hypokalemia) 33/133 (24.8%) 3/32 (9.4%) 3/27 (11.1%)
    Sodium, serum-low (hyponatremia) 58/133 (43.6%) 6/32 (18.8%) 5/27 (18.5%)
    Metabolic/Laboratory - elevated blood urea nitrogen 11/133 (8.3%) 1/32 (3.1%) 2/27 (7.4%)
    Musculoskeletal and connective tissue disorders
    Muscle weakness, not d/t neuropathy - Extrem-lower 2/133 (1.5%) 3/32 (9.4%) 2/27 (7.4%)
    Muscle weakness, not d/t neuropathy - body/general 20/133 (15%) 2/32 (6.3%) 2/27 (7.4%)
    Pain - Back 6/133 (4.5%) 3/32 (9.4%) 4/27 (14.8%)
    Pain - Extremity-limb 8/133 (6%) 3/32 (9.4%) 5/27 (18.5%)
    Pain - Joint 6/133 (4.5%) 2/32 (6.3%) 4/27 (14.8%)
    Nervous system disorders
    Dizziness 16/133 (12%) 0/32 (0%) 4/27 (14.8%)
    Neuropathy: sensory 2/133 (1.5%) 0/32 (0%) 2/27 (7.4%)
    Pain - Head/headache 14/133 (10.5%) 0/32 (0%) 1/27 (3.7%)
    Taste alteration (dysgeusia) 9/133 (6.8%) 0/32 (0%) 2/27 (7.4%)
    Psychiatric disorders
    Confusion 9/133 (6.8%) 1/32 (3.1%) 0/27 (0%)
    Insomnia 16/133 (12%) 5/32 (15.6%) 2/27 (7.4%)
    Mood alteration - anxiety 12/133 (9%) 0/32 (0%) 0/27 (0%)
    Mood alteration - depression 12/133 (9%) 1/32 (3.1%) 3/27 (11.1%)
    Renal and urinary disorders
    Glomerular filtration rate 6/133 (4.5%) 2/32 (6.3%) 1/27 (3.7%)
    Urinary frequency/urgency 8/133 (6%) 0/32 (0%) 2/27 (7.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 26/133 (19.5%) 0/32 (0%) 3/27 (11.1%)
    Dyspnea (shortness of breath) 33/133 (24.8%) 1/32 (3.1%) 2/27 (7.4%)
    Hemorrhage, pulmonary/upper respiratory - Nose 12/133 (9%) 0/32 (0%) 0/27 (0%)
    Hypoxia 10/133 (7.5%) 0/32 (0%) 0/27 (0%)
    Pleural effusion (non-malignant) 9/133 (6.8%) 0/32 (0%) 0/27 (0%)
    Skin and subcutaneous tissue disorders
    Hair loss/Alopecia (scalp or body) 1/133 (0.8%) 2/32 (6.3%) 3/27 (11.1%)
    Nail changes 0/133 (0%) 1/32 (3.1%) 2/27 (7.4%)
    Petechiae/purpura (hemorrhage into skin or mucosa) 16/133 (12%) 1/32 (3.1%) 0/27 (0%)
    Pruritus/itching 8/133 (6%) 0/32 (0%) 3/27 (11.1%)
    Rash/desquamation 29/133 (21.8%) 3/32 (9.4%) 3/27 (11.1%)
    Rash: erythema multiforme 0/133 (0%) 0/32 (0%) 2/27 (7.4%)
    Sweating (diaphoresis) 12/133 (9%) 2/32 (6.3%) 1/27 (3.7%)
    Vascular disorders
    Hypotension 11/133 (8.3%) 0/32 (0%) 1/27 (3.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Study Statistician
    Organization SWOG
    Phone 206-667-4623
    Email
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00658814
    Other Study ID Numbers:
    • NCI-2009-00790
    • NCI-2009-00790
    • SWOG-S0703
    • CDR0000593117
    • S0703
    • S0703
    • U10CA032102
    First Posted:
    Apr 15, 2008
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Mar 1, 2022