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

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ClinicalTrials.gov Identifier: NCT00658814
Recruitment Status : Active, not recruiting
First Posted : April 15, 2008
Results First Posted : January 6, 2014
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: Azacitidine
Drug: Gemtuzumab Ozogamicin
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Hide 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
Reason Not Completed
Adverse Event             1             3
Withdrawal by Subject             3             4
Progression/Relapse             0             1
Death             1             4
Not protocol specified             2             4
Not eligible             1             2
Period Title: Consolidation Therapy
Started 24 13
Eligible 22 11
Completed 22 10
Not Completed 2 3
Reason Not Completed
Not protocol specified             0             1
Not eligible             2             2
Period Title: Maintenance Therapy
Started 20 8
Eligible 19 8
Completed 17 7
Not Completed 3 1
Reason Not Completed
Adverse Event             1             1
Not protocol specified             1             0
Not eligible             1             0
Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Total
Hide 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 Number of Baseline Participants 79 54 133
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 79 participants 54 participants 133 participants
71.2
(60.5 to 88.7)
76
(70.3 to 87)
73.4
(60.5 to 88.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 54 participants 133 participants
Female
30
  38.0%
21
  38.9%
51
  38.3%
Male
49
  62.0%
33
  61.1%
82
  61.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 54 participants 133 participants
Asian 1 0 1
Black or African American 1 4 5
White 77 50 127
Hispanic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 54 participants 133 participants
Yes 3 1 4
No 64 50 114
Unknown 12 3 15
1.Primary Outcome
Title Complete Response
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Hide 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)

Overall Number of Participants Analyzed 79 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44
(33 to 56)
35
(23 to 49)
2.Primary Outcome
Title 30-Day Survival
Hide Description Patients surviving more than 30 days after study registration
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Hide 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)

Overall Number of Participants Analyzed 79 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92
(84 to 97)
87
(75 to 95)
3.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 5 years
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Hide 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
Hide 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)
Overall Number of Participants Analyzed 133 32 27
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 5 0 0
AST, SGOT 4 0 0
Adult respiratory distress syndrome (ARDS) 1 0 0
Albumin, serum-low (hypoalbuminemia) 5 1 0
Anorexia 5 1 0
Bilirubin (hyperbilirubinemia) 3 0 0
Calcium, serum-low (hypocalcemia) 6 0 0
Carbon monoxide diffusion capacity (DL(co)) 1 0 0
Cardiac Arrhythmia-Atrial fibrilation 1 0 0
Cardiac General-cardiopulmonary disease 1 0 0
Cardiac General-Chest Pain 1 0 0
Cardiac troponin I (cTnI) 1 0 0
Cardiac-ischemia/infarction 1 0 0
Conduction abnormality NOS 1 0 0
Confusion 1 0 0
Constipation 2 0 0
Cytokine release syndrome/acute infusion reaction 1 0 0
Death - Disease progression NOS 1 0 0
Death - Multi-organ failure 2 0 0
Death not associated with CTCAE term - Death NOS 1 0 0
Dehydration 1 0 0
Diarrhea 2 0 0
Dyspnea (shortness of breath) 5 1 2
Edema: limb 1 0 0
Fatigue (asthenia, lethargy, malaise) 18 1 1
Febrile neutropenia 50 0 0
Glucose, serum-high (hyperglycemia) 10 3 2
Hemoglobin 73 1 1
Hemorrhage, CNS 1 0 0
Hemorrhage, GI - Stomach 1 0 0
Hemorrhage, GI - Upper GI NOS 1 0 0
Hemorrhage/Bleeding-platelets and red blood cells 1 0 0
Hepatobiliary/Pancreas-venoocclusive disease 1 0 0
Hypertension 1 0 0
Hypotension 2 0 0
Hypoxia 4 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 16 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel 2 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Colon 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth 3 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Kidney 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 8 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus 2 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 6 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 3 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 2 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 0 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 1 0 0
Infection with unknown ANC - Blood 1 0 0
Infection with unknown ANC - Lung (pneumonia) 1 0 0
Infection with unknown ANC - Skin (cellulitis) 1 0 0
Infection-Aspirgillosis 1 0 0
Infection-bacteremia 1 0 0
Left ventricular systolic dysfunction 1 0 0
Leukocytes (total WBC) 80 18 6
Liver dysfunction/failure (clinical) 0 1 0
Lymphopenia 23 0 1
Mood alteration - depression 2 0 0
Mucositis/stomatitis (functional/symp) - Oral cav 1 0 0
Muscle weakness, not d/t neuropathy - body/general 4 0 0
Neutrophils/granulocytes (ANC/AGC) 85 21 10
Pain - Cardiac/heart 2 0 0
Petechiae/purpura (hemorrhage into skin or mucosa) 1 0 0
Phosphate, serum-low (hypophosphatemia) 4 0 0
Platelets 85 12 3
Pleural effusion (non-malignant) 1 0 0
Pneumonitis/pulmonary infiltrates 1 0 0
Potassium, serum-low (hypokalemia) 5 0 0
Pulmonary/Upper Respiratory-pulmonary edema 2 0 0
Rash/desquamation 1 0 0
SVT and nodal arrhythmia - Atrial fibrillation 2 0 0
SVT and nodal arrhythmia - SVT tachycardia 1 0 0
Sodium, serum-low (hyponatremia) 5 0 0
Sudden death 1 0 0
Thrombosis/thrombus/embolism 2 0 0
4.Secondary Outcome
Title Relapse-free Survival
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Hide 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)

Overall Number of Participants Analyzed 35 19
Median (95% Confidence Interval)
Unit of Measure: months
8
(5 to 13)
7
(6 to 12)
Time Frame Up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/133 (41.35%)   1/32 (3.13%)   3/27 (11.11%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  10/133 (7.52%)  0/32 (0.00%)  0/27 (0.00%) 
Hemoglobin  1  4/133 (3.01%)  0/32 (0.00%)  0/27 (0.00%) 
Cardiac disorders       
Cardiac-ischemia/infarction  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Conduction abnormality NOS  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Left ventricular systolic dysfunction  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Pain - Cardiac/heart  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
SVT and nodal arrhythmia - Atrial fibrillation  1  3/133 (2.26%)  0/32 (0.00%)  0/27 (0.00%) 
SVT and nodal arrhythmia - SVT tachycardia  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
SVT and nodal arrhythmia - Sinus tachycardia  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Ventricular arrhythmia - Ventricular fibrillation  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Gastrointestinal disorders       
Colitis  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Hemorrhage, GI - Stomach  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Hemorrhage, GI - Upper GI NOS  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Ileus, GI (functional obstruction of bowel)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Obstruction, GI - Small bowel NOS  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
General disorders       
Death - Multi-organ failure  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Death not associated with CTCAE term - Death NOS  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Fatigue (asthenia, lethargy, malaise)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Sudden death  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Hepatobiliary disorders       
Liver dysfunction/failure (clinical)  1  0/133 (0.00%)  1/32 (3.13%)  0/27 (0.00%) 
Immune system disorders       
Cytokine release syndrome/acute infusion reaction  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  7/133 (5.26%)  0/32 (0.00%)  0/27 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel  1  1/133 (0.75%)  1/32 (3.13%)  0/27 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  7/133 (5.26%)  0/32 (0.00%)  0/27 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Skin  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - UTI  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  3/133 (2.26%)  0/32 (0.00%)  0/27 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  0/133 (0.00%)  0/32 (0.00%)  1/27 (3.70%) 
Infection with unknown ANC - Blood  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Infection with unknown ANC - Lung (pneumonia)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Infection-Other (Specify):bacteremia  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Injury, poisoning and procedural complications       
Fracture  1  0/133 (0.00%)  0/32 (0.00%)  1/27 (3.70%) 
Hemorrhage/bleeding w/surgery, intra- or post-op  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
AST, SGOT  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Carbon monoxide diffusion capacity (DL(co))  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Cardiac troponin I (cTnI)  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Creatinine  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Leukocytes (total WBC)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  3/133 (2.26%)  0/32 (0.00%)  0/27 (0.00%) 
Platelets  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Metabolism and nutrition disorders       
Acidosis (metabolic or respiratory)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Albumin, serum-low (hypoalbuminemia)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Calcium, serum-low (hypocalcemia)  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Glucose, serum-high (hyperglycemia)  1  2/133 (1.50%)  0/32 (0.00%)  1/27 (3.70%) 
Magnesium, serum-low (hypomagnesemia)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Tumor lysis syndrome  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - body/general  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Pain - Back  1  0/133 (0.00%)  0/32 (0.00%)  1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death - Disease progression NOS  1  12/133 (9.02%)  0/32 (0.00%)  0/27 (0.00%) 
Myelodysplasia  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Nervous system disorders       
CNS cerebrovascular ischemia  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Encephalopathy  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Hemorrhage, CNS  1  3/133 (2.26%)  0/32 (0.00%)  0/27 (0.00%) 
Neurology-Other  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Psychiatric disorders       
Confusion  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Mood alteration - depression  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Renal and urinary disorders       
Proteinuria  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Renal failure  1  1/133 (0.75%)  0/32 (0.00%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders       
Carbon monoxide diffusion capacity (DL(co))  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Cough  1  0/133 (0.00%)  0/32 (0.00%)  1/27 (3.70%) 
Dyspnea (shortness of breath)  1  5/133 (3.76%)  0/32 (0.00%)  1/27 (3.70%) 
Hypoxia  1  4/133 (3.01%)  0/32 (0.00%)  0/27 (0.00%) 
Pleural effusion (non-malignant)  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Pulmonary/Upper Respiratory-Other (Specify):Pulmonary Edema  1  2/133 (1.50%)  0/32 (0.00%)  0/27 (0.00%) 
Pulmonary/Upper Respiratory-Other (Specify):Respiratory distress  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Vascular disorders       
Hypertension  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Hypotension  1  6/133 (4.51%)  0/32 (0.00%)  0/27 (0.00%) 
Thrombosis/thrombus/embolism  1  3/133 (2.26%)  0/32 (0.00%)  0/27 (0.00%) 
Vascular-Other (Specify):pariatal to occiptal lobe  1  1/133 (0.75%)  0/32 (0.00%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remission Induction Chemotherapy Consolidation Therapy Maintenance Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   130/133 (97.74%)   32/32 (100.00%)   26/27 (96.30%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  49/133 (36.84%)  1/32 (3.13%)  0/27 (0.00%) 
Hemoglobin  1  98/133 (73.68%)  20/32 (62.50%)  15/27 (55.56%) 
Eye disorders       
Watery eye (epiphora, tearing)  1  0/133 (0.00%)  3/32 (9.38%)  0/27 (0.00%) 
Gastrointestinal disorders       
Constipation  1  47/133 (35.34%)  6/32 (18.75%)  10/27 (37.04%) 
Diarrhea  1  35/133 (26.32%)  1/32 (3.13%)  7/27 (25.93%) 
Heartburn/dyspepsia  1  8/133 (6.02%)  1/32 (3.13%)  1/27 (3.70%) 
Hemorrhoids  1  8/133 (6.02%)  0/32 (0.00%)  1/27 (3.70%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  12/133 (9.02%)  1/32 (3.13%)  1/27 (3.70%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  8/133 (6.02%)  1/32 (3.13%)  0/27 (0.00%) 
Nausea  1  56/133 (42.11%)  5/32 (15.63%)  5/27 (18.52%) 
Pain - Abdomen NOS  1  14/133 (10.53%)  3/32 (9.38%)  2/27 (7.41%) 
Vomiting  1  27/133 (20.30%)  0/32 (0.00%)  2/27 (7.41%) 
General disorders       
Edema: limb  1  30/133 (22.56%)  3/32 (9.38%)  3/27 (11.11%) 
Fatigue (asthenia, lethargy, malaise)  1  81/133 (60.90%)  15/32 (46.88%)  11/27 (40.74%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  14/133 (10.53%)  0/32 (0.00%)  1/27 (3.70%) 
Injection site reaction/extravasation changes  1  9/133 (6.77%)  5/32 (15.63%)  9/27 (33.33%) 
Pain - Chest/thorax NOS  1  7/133 (5.26%)  1/32 (3.13%)  1/27 (3.70%) 
Rigors/chills  1  21/133 (15.79%)  2/32 (6.25%)  1/27 (3.70%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  15/133 (11.28%)  1/32 (3.13%)  1/27 (3.70%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Skin  1  9/133 (6.77%)  0/32 (0.00%)  0/27 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  1/133 (0.75%)  1/32 (3.13%)  2/27 (7.41%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  30/133 (22.56%)  5/32 (15.63%)  3/27 (11.11%) 
AST, SGOT  1  35/133 (26.32%)  10/32 (31.25%)  6/27 (22.22%) 
Alkaline phosphatase  1  22/133 (16.54%)  4/32 (12.50%)  4/27 (14.81%) 
Bilirubin (hyperbilirubinemia)  1  18/133 (13.53%)  3/32 (9.38%)  5/27 (18.52%) 
Creatinine  1  31/133 (23.31%)  6/32 (18.75%)  7/27 (25.93%) 
Leukocytes (total WBC)  1  87/133 (65.41%)  23/32 (71.88%)  16/27 (59.26%) 
Lymphopenia  1  40/133 (30.08%)  4/32 (12.50%)  1/27 (3.70%) 
Neutrophils/granulocytes (ANC/AGC)  1  91/133 (68.42%)  23/32 (71.88%)  14/27 (51.85%) 
Platelets  1  100/133 (75.19%)  25/32 (78.13%)  11/27 (40.74%) 
Weight loss  1  13/133 (9.77%)  3/32 (9.38%)  3/27 (11.11%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  63/133 (47.37%)  13/32 (40.63%)  9/27 (33.33%) 
Anorexia  1  45/133 (33.83%)  5/32 (15.63%)  5/27 (18.52%) 
Calcium, serum-high (hypercalcemia)  1  3/133 (2.26%)  3/32 (9.38%)  3/27 (11.11%) 
Calcium, serum-low (hypocalcemia)  1  45/133 (33.83%)  4/32 (12.50%)  3/27 (11.11%) 
Glucose, serum-high (hyperglycemia)  1  69/133 (51.88%)  18/32 (56.25%)  19/27 (70.37%) 
Glucose, serum-low (hypoglycemia)  1  7/133 (5.26%)  2/32 (6.25%)  3/27 (11.11%) 
Magnesium, serum-high (hypermagnesemia)  1  11/133 (8.27%)  0/32 (0.00%)  0/27 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  9/133 (6.77%)  4/32 (12.50%)  2/27 (7.41%) 
Phosphate, serum-low (hypophosphatemia)  1  19/133 (14.29%)  1/32 (3.13%)  0/27 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  7/133 (5.26%)  0/32 (0.00%)  1/27 (3.70%) 
Potassium, serum-low (hypokalemia)  1  33/133 (24.81%)  3/32 (9.38%)  3/27 (11.11%) 
Sodium, serum-low (hyponatremia)  1  58/133 (43.61%)  6/32 (18.75%)  5/27 (18.52%) 
Metabolic/Laboratory - elevated blood urea nitrogen  1  11/133 (8.27%)  1/32 (3.13%)  2/27 (7.41%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - Extrem-lower  1  2/133 (1.50%)  3/32 (9.38%)  2/27 (7.41%) 
Muscle weakness, not d/t neuropathy - body/general  1  20/133 (15.04%)  2/32 (6.25%)  2/27 (7.41%) 
Pain - Back  1  6/133 (4.51%)  3/32 (9.38%)  4/27 (14.81%) 
Pain - Extremity-limb  1  8/133 (6.02%)  3/32 (9.38%)  5/27 (18.52%) 
Pain - Joint  1  6/133 (4.51%)  2/32 (6.25%)  4/27 (14.81%) 
Nervous system disorders       
Dizziness  1  16/133 (12.03%)  0/32 (0.00%)  4/27 (14.81%) 
Neuropathy: sensory  1  2/133 (1.50%)  0/32 (0.00%)  2/27 (7.41%) 
Pain - Head/headache  1  14/133 (10.53%)  0/32 (0.00%)  1/27 (3.70%) 
Taste alteration (dysgeusia)  1  9/133 (6.77%)  0/32 (0.00%)  2/27 (7.41%) 
Psychiatric disorders       
Confusion  1  9/133 (6.77%)  1/32 (3.13%)  0/27 (0.00%) 
Insomnia  1  16/133 (12.03%)  5/32 (15.63%)  2/27 (7.41%) 
Mood alteration - anxiety  1  12/133 (9.02%)  0/32 (0.00%)  0/27 (0.00%) 
Mood alteration - depression  1  12/133 (9.02%)  1/32 (3.13%)  3/27 (11.11%) 
Renal and urinary disorders       
Glomerular filtration rate  1  6/133 (4.51%)  2/32 (6.25%)  1/27 (3.70%) 
Urinary frequency/urgency  1  8/133 (6.02%)  0/32 (0.00%)  2/27 (7.41%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  26/133 (19.55%)  0/32 (0.00%)  3/27 (11.11%) 
Dyspnea (shortness of breath)  1  33/133 (24.81%)  1/32 (3.13%)  2/27 (7.41%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  12/133 (9.02%)  0/32 (0.00%)  0/27 (0.00%) 
Hypoxia  1  10/133 (7.52%)  0/32 (0.00%)  0/27 (0.00%) 
Pleural effusion (non-malignant)  1  9/133 (6.77%)  0/32 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders       
Hair loss/Alopecia (scalp or body)  1  1/133 (0.75%)  2/32 (6.25%)  3/27 (11.11%) 
Nail changes  1  0/133 (0.00%)  1/32 (3.13%)  2/27 (7.41%) 
Petechiae/purpura (hemorrhage into skin or mucosa)  1  16/133 (12.03%)  1/32 (3.13%)  0/27 (0.00%) 
Pruritus/itching  1  8/133 (6.02%)  0/32 (0.00%)  3/27 (11.11%) 
Rash/desquamation  1  29/133 (21.80%)  3/32 (9.38%)  3/27 (11.11%) 
Rash: erythema multiforme  1  0/133 (0.00%)  0/32 (0.00%)  2/27 (7.41%) 
Sweating (diaphoresis)  1  12/133 (9.02%)  2/32 (6.25%)  1/27 (3.70%) 
Vascular disorders       
Hypotension  1  11/133 (8.27%)  0/32 (0.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: SWOG
Phone: 206-667-4623
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00658814     History of Changes
Other Study ID Numbers: NCI-2009-00790
NCI-2009-00790 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000593117
SWOG-S0703
S0703 ( Other Identifier: SWOG )
S0703 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: April 12, 2008
First Posted: April 15, 2008
Results First Submitted: July 22, 2013
Results First Posted: January 6, 2014
Last Update Posted: December 5, 2018