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Trial record 13 of 325 for:    CYTARABINE AND DAUNORUBICIN

Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00742625
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : February 5, 2013
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: daunorubicin hydrochloride
Drug: cytarabine
Drug: bortezomib
Enrollment 95
Recruitment Details Between September 2008 and February 2010, 98 participants were recruited at 15 CALGB member institutions and their affiliated hospitals.
Pre-assignment Details Three (3) participants did not begin treatment and were excluded from all analyses per study design
Arm/Group Title Bortezomib + Daunorubicin + Cytarabine
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Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)

Period Title: Remission Induction
Started 95
Completed 41
Not Completed 54
Reason Not Completed
Progression             6
Failed induction             8
Adverse Event             3
Death             10
Refusal             5
Non protocol treatment             17
Other, not specified             5
Period Title: Consolidation
Started 41
Completed 20
Not Completed 21
Reason Not Completed
Progression             5
Adverse Event             1
Death             1
Refused             1
Non protocol therapy             13
Arm/Group Title Bortezomib + Daunorubicin + Cytarabine
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Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)

Overall Number of Baseline Participants 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 95 participants
67
(60 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants
Female
42
  44.2%
Male
53
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants
95
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants
0 - Fully Active 31
1 - Ambulatory, restricted strenuous activity 55
2 - Ambulatory, unable to perform work activities 9
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
1.Primary Outcome
Title Remission Induction Response
Hide Description

Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML)

A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction.

A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).

A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion.

Time Frame 2 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Daunorubicin + Cytarabine
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Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)

Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: participants
Complete response 62
Complete response with incomplete platelet recover 4
2.Primary Outcome
Title Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine
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DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs.

Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death.

Time Frame during consolidation cycle 1 (42 days)
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Hide Analysis Population Description
Participants who were registered to bortezomib consolidation were included in the analysis.
Arm/Group Title Bortezomib (0.7 mg/m^2) + Int-DAC Bortezomib (1.0 mg/m^2) + Int-DAC Bortezomib (1.3 mg/m^2) + Int-DAC
Hide Arm/Group Description:
Bortezomib (0.7 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
Bortezomib (1.0 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
Bortezomib (1.3 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
Overall Number of Participants Analyzed 3 3 17
Measure Type: Number
Unit of Measure: participants
0 0 1
3.Secondary Outcome
Title Disease-free Survival
Hide Description Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 10 years)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Daunorubicin + Cytarabine
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Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)

Overall Number of Participants Analyzed 95
Median (95% Confidence Interval)
Unit of Measure: months
8
(6 to 12)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib + Daunorubicin + Cytarabine
Hide Arm/Group Description:

Bortezomib:

Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)

Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11

Cytarabine:

Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5

Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)

Overall Number of Participants Analyzed 95
Median (95% Confidence Interval)
Unit of Measure: months
12
(8 to 19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortezomib + Daunorubicin + Cytarabine
Hide Arm/Group Description Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
All-Cause Mortality
Bortezomib + Daunorubicin + Cytarabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib + Daunorubicin + Cytarabine
Affected / at Risk (%) # Events
Total   43/95 (45.26%)    
Blood and lymphatic system disorders   
DIC (disseminated intravascular coagulation)  1  1/95 (1.05%)  1
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe  1  24/95 (25.26%)  27
Hemoglobin  1  43/95 (45.26%)  51
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)  1  1/95 (1.05%)  1
Lymphatics - Other (Specify __)  1  1/95 (1.05%)  1
Cardiac disorders   
Cardiac Arrhythmia - Other (Specify __)  1  13/95 (13.68%)  15
Cardiac ischemia/infarction  1  6/95 (6.32%)  6
Cardiopulmonary arrest cause unknown (non-fatal)  1  1/95 (1.05%)  1
Left ventricular diastolic dysfunction  1  1/95 (1.05%)  1
Left ventricular systolic dysfunction  1  16/95 (16.84%)  18
Palpitations  1  2/95 (2.11%)  2
Supraventricular and nodal arrhythmia  1  8/95 (8.42%)  15
Endocrine disorders   
Endocrine - Other (Specify __)  1  1/95 (1.05%)  1
Thyroid function high (hyperthyroidism thyrotoxicosis)  1  1/95 (1.05%)  1
Eye disorders   
Ocular/Visual - Other (Specify __)  1  1/95 (1.05%)  1
Gastrointestinal disorders   
Colitis  1  1/95 (1.05%)  1
Constipation  1  9/95 (9.47%)  9
Diarrhea  1  36/95 (37.89%)  40
Distension/bloating, abdominal  1  4/95 (4.21%)  4
Dry mouth/salivary gland (xerostomia)  1  2/95 (2.11%)  2
Dysphagia (difficulty swallowing)  1  5/95 (5.26%)  5
Enteritis (inflammation of the small bowel)  1  2/95 (2.11%)  2
Esophagitis  1  1/95 (1.05%)  1
Heartburn/dyspepsia  1  1/95 (1.05%)  2
Hemorrhage, GI  1  6/95 (6.32%)  6
Ileus GI (functional obstruction of bowel i.e. neuroconstipation)  1  1/95 (1.05%)  1
Mucositis/stomatitis (clinical exam)  1  4/95 (4.21%)  5
Mucositis/stomatitis (functional/symptomatic)  1  1/95 (1.05%)  1
Nausea  1  30/95 (31.58%)  32
Typhlitis (cecal inflammation)  1  2/95 (2.11%)  2
Ulcer GI  1  1/95 (1.05%)  1
Vomiting  1  17/95 (17.89%)  19
General disorders   
Constitutional Symptoms - Other (Specify __)  1  1/95 (1.05%)  1
Death not associated with CTCAE term  1  2/95 (2.11%)  2
Edema: limb  1  8/95 (8.42%)  8
Edema: trunk/genital  1  3/95 (3.16%)  3
Edema:head and neck  1  1/95 (1.05%)  1
Fatigue (asthenia, lethargy, malaise)  1  16/95 (16.84%)  17
Fever  1  1/95 (1.05%)  1
Rigors/chills  1  5/95 (5.26%)  5
Hepatobiliary disorders   
Liver dysfunction/failure (clinical)  1  1/95 (1.05%)  1
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  2/95 (2.11%)  2
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  2/95 (2.11%)  2
Infection  1  29/95 (30.53%)  56
Infection - Other (Specify __)  1  8/95 (8.42%)  8
Infection with normal ANC or Grade 1 or 2 neutrophils  1  10/95 (10.53%)  12
Infection with unknown ANC  1  5/95 (5.26%)  5
Opportunistic infection associated with >=Grade 2 Lymphopenia  1  2/95 (2.11%)  2
Injury, poisoning and procedural complications   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  1/95 (1.05%)  1
Fracture  1  1/95 (1.05%)  1
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  26/95 (27.37%)  29
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  29/95 (30.53%)  32
Alkaline phosphatase  1  10/95 (10.53%)  10
Bilirubin (hyperbilirubinemia)  1  25/95 (26.32%)  28
Carbon monoxide diffusion capacity (DL(co))  1  5/95 (5.26%)  5
Cardiac troponin I (cTnI)  1  1/95 (1.05%)  1
Creatinine  1  8/95 (8.42%)  8
GGT (gamma-Glutamyl transpeptidase)  1  2/95 (2.11%)  3
INR (International Normalized Ratio of prothrombin time)  1  3/95 (3.16%)  3
Leukocytes (total WBC)  1  20/95 (21.05%)  24
Lymphopenia  1  16/95 (16.84%)  20
Metabolic/Laboratory - Other (Specify __)  1  2/95 (2.11%)  2
Neutrophils/granulocytes (ANC/AGC)  1  43/95 (45.26%)  50
PTT (Partial Thromboplastin Time)  1  4/95 (4.21%)  4
Platelets  1  43/95 (45.26%)  51
Prolonged QTc interval  1  6/95 (6.32%)  6
Weight gain  1  1/95 (1.05%)  1
Weight loss  1  3/95 (3.16%)  3
Metabolism and nutrition disorders   
Acidosis (metabolic or respiratory)  1  3/95 (3.16%)  3
Albumin, serum-low (hypoalbuminemia)  1  19/95 (20.00%)  20
Alkalosis (metabolic or respiratory)  1  4/95 (4.21%)  4
Anorexia  1  10/95 (10.53%)  10
Calcium serum-low (hypocalcemia)  1  12/95 (12.63%)  12
Dehydration  1  4/95 (4.21%)  4
Glucose serum-high (hyperglycemia)  1  13/95 (13.68%)  13
Glucose serum-low (hypoglycemia)  1  1/95 (1.05%)  1
Magnesium serum-high (hypermagnesemia)  1  4/95 (4.21%)  4
Magnesium serum-low (hypomagnesemia)  1  4/95 (4.21%)  4
Phosphate serum-low (hypophosphatemia)  1  14/95 (14.74%)  14
Potassium serum-high (hyperkalemia)  1  5/95 (5.26%)  5
Potassium serum-low (hypokalemia)  1  19/95 (20.00%)  21
Sodium serum-high (hypernatremia)  1  2/95 (2.11%)  2
Sodium serum-low (hyponatremia)  1  6/95 (6.32%)  6
Uric acid serum-high (hyperuricemia)  1  5/95 (5.26%)  5
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy)  1  8/95 (8.42%)  11
Nervous system disorders   
CNS cerebrovascular ischemia  1  2/95 (2.11%)  2
Dizziness  1  6/95 (6.32%)  7
Hemorrhage CNS  1  1/95 (1.05%)  1
Neuropathy: cranial  1  1/95 (1.05%)  2
Neuropathy: motor  1  3/95 (3.16%)  3
Neuropathy: sensory  1  16/95 (16.84%)  21
Pain  1  12/95 (12.63%)  30
Somnolence/depressed level of consciousness  1  7/95 (7.37%)  7
Speech impairment (e.g., dysphasia or aphasia)  1  1/95 (1.05%)  1
Syncope (fainting)  1  3/95 (3.16%)  3
Taste alteration (dysgeusia)  1  1/95 (1.05%)  1
Vasovagal episode  1  1/95 (1.05%)  1
Psychiatric disorders   
Confusion  1  5/95 (5.26%)  5
Insomnia  1  5/95 (5.26%)  5
Mood alteration  1  6/95 (6.32%)  7
Personality/behavioral  1  1/95 (1.05%)  1
Psychosis (hallucinations/delusions)  1  2/95 (2.11%)  2
Renal and urinary disorders   
Glomerular filtration rate  1  1/95 (1.05%)  1
Hemorrhage GU  1  1/95 (1.05%)  1
Renal failure  1  5/95 (5.26%)  5
Renal/Genitourinary - Other (Specify __)  1  3/95 (3.16%)  3
Urinary retention (including neurogenic bladder)  1  1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders   
Adult Respiratory Distress Syndrome (ARDS)  1  7/95 (7.37%)  7
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)  1  1/95 (1.05%)  1
Aspiration  1  1/95 (1.05%)  1
Cough  1  4/95 (4.21%)  4
Dyspnea (shortness of breath)  1  19/95 (20.00%)  20
Edema larynx  1  2/95 (2.11%)  2
Hemorrhage pulmonary/upper respiratory  1  4/95 (4.21%)  5
Hypoxia  1  16/95 (16.84%)  16
Pleural effusion (non-malignant)  1  5/95 (5.26%)  5
Pneumonitis/pulmonary infiltrates  1  1/95 (1.05%)  1
Pulmonary/Upper Respiratory - Other (Specify __)  1  4/95 (4.21%)  4
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify __)  1  2/95 (2.11%)  2
Hair loss/alopecia (scalp or body)  1  1/95 (1.05%)  1
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  2/95 (2.11%)  2
Rash/desquamation  1  22/95 (23.16%)  23
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  1/95 (1.05%)  1
Sweating (diaphoresis)  1  2/95 (2.11%)  2
Vascular disorders   
Acute vascular leak syndrome  1  1/95 (1.05%)  1
Flushing  1  1/95 (1.05%)  1
Hematoma  1  2/95 (2.11%)  2
Hemorrhage/Bleeding - Other (Specify __)  1  1/95 (1.05%)  1
Hypertension  1  6/95 (6.32%)  6
Hypotension  1  26/95 (27.37%)  27
Phlebitis (including superficial thrombosis)  1  1/95 (1.05%)  1
Thrombosis/thrombus/embolism  1  1/95 (1.05%)  1
Visceral arterial ischemia (non-myocardial)  1  1/95 (1.05%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortezomib + Daunorubicin + Cytarabine
Affected / at Risk (%) # Events
Total   77/95 (81.05%)    
Blood and lymphatic system disorders   
DIC (disseminated intravascular coagulation)  1  1/95 (1.05%)  1
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe  1  50/95 (52.63%)  67
Hemoglobin  1  76/95 (80.00%)  146
Lymphatics - Other (Specify __)  1  3/95 (3.16%)  3
Cardiac disorders   
Cardiac Arrhythmia - Other (Specify __)  1  6/95 (6.32%)  7
Left ventricular diastolic dysfunction  1  1/95 (1.05%)  1
Left ventricular systolic dysfunction  1  12/95 (12.63%)  14
Pericardial effusion (non-malignant)  1  1/95 (1.05%)  1
Pericarditis  1  1/95 (1.05%)  1
Supraventricular and nodal arrhythmia  1  11/95 (11.58%)  12
Endocrine disorders   
Thyroid function, low (hypothyroidism)  1  1/95 (1.05%)  1
Eye disorders   
Ocular surface disease  1  1/95 (1.05%)  1
Ocular/Visual - Other (Specify __)  1  2/95 (2.11%)  2
Gastrointestinal disorders   
Colitis  1  2/95 (2.11%)  2
Constipation  1  10/95 (10.53%)  12
Diarrhea  1  63/95 (66.32%)  86
Dry mouth/salivary gland (xerostomia)  1  3/95 (3.16%)  3
Dysphagia (difficulty swallowing)  1  3/95 (3.16%)  3
Fistula, GI  1  2/95 (2.11%)  2
Gastrointestinal - Other (Specify __)  1  2/95 (2.11%)  2
Heartburn/dyspepsia  1  1/95 (1.05%)  1
Hemorrhage, GI  1  4/95 (4.21%)  5
Hemorrhoids  1  2/95 (2.11%)  2
Mucositis/stomatitis (clinical exam)  1  12/95 (12.63%)  15
Mucositis/stomatitis (functional/symptomatic)  1  2/95 (2.11%)  2
Nausea  1  61/95 (64.21%)  95
Typhlitis (cecal inflammation)  1  2/95 (2.11%)  2
Ulcer GI  1  1/95 (1.05%)  1
Ulcer, GI  1  1/95 (1.05%)  1
Vomiting  1  38/95 (40.00%)  49
General disorders   
Edema: limb  1  15/95 (15.79%)  18
Edema: trunk/genital  1  2/95 (2.11%)  3
Fatigue (asthenia, lethargy, malaise)  1  26/95 (27.37%)  36
Fever  1  3/95 (3.16%)  5
Pain - Other (Specify, __)  1  3/95 (3.16%)  3
Rigors/chills  1  16/95 (16.84%)  19
Hepatobiliary disorders   
Hepatobiliary/Pancreas - Other (Specify __)  1  1/95 (1.05%)  1
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  2/95 (2.11%)  2
Allergy/Immunology - Other (Specify __)  1  2/95 (2.11%)  3
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  1/95 (1.05%)  1
Infection  1  46/95 (48.42%)  73
Infection - Other (Specify __)  1  6/95 (6.32%)  7
Infection with normal ANC or Grade 1 or 2 neutrophils  1  6/95 (6.32%)  7
Infection with unknown ANC  1  3/95 (3.16%)  3
Injury, poisoning and procedural complications   
Thrombosis/embolism (vascular access-related)  1  2/95 (2.11%)  2
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  40/95 (42.11%)  65
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  49/95 (51.58%)  73
Alkaline phosphatase  1  16/95 (16.84%)  19
Bilirubin (hyperbilirubinemia)  1  34/95 (35.79%)  43
Carbon monoxide diffusion capacity (DL(co))  1  10/95 (10.53%)  10
Creatinine  1  5/95 (5.26%)  7
GGT (gamma-Glutamyl transpeptidase)  1  2/95 (2.11%)  4
INR (International Normalized Ratio of prothrombin time)  1  4/95 (4.21%)  4
Leukocytes (total WBC)  1  23/95 (24.21%)  39
Lymphopenia  1  17/95 (17.89%)  28
Metabolic/Laboratory - Other (Specify __)  1  2/95 (2.11%)  2
Neuroendocrine: ADH secretion abnormality (e.g. SIADH or low ADH)  1  1/95 (1.05%)  1
Neutrophils/granulocytes (ANC/AGC)  1  76/95 (80.00%)  142
PTT (Partial Thromboplastin Time)  1  8/95 (8.42%)  10
Platelets  1  75/95 (78.95%)  144
Prolonged QTc interval  1  2/95 (2.11%)  2
Weight loss  1  2/95 (2.11%)  3
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  24/95 (25.26%)  30
Alkalosis (metabolic or respiratory)  1  2/95 (2.11%)  2
Anorexia  1  22/95 (23.16%)  26
Bicarbonate, serum-low  1  1/95 (1.05%)  1
Calcium serum-high (hypercalcemia)  1  2/95 (2.11%)  3
Calcium serum-low (hypocalcemia)  1  26/95 (27.37%)  32
Dehydration  1  1/95 (1.05%)  1
Glucose serum-high (hyperglycemia)  1  23/95 (24.21%)  39
Glucose serum-low (hypoglycemia)  1  2/95 (2.11%)  2
Magnesium serum-high (hypermagnesemia)  1  1/95 (1.05%)  1
Magnesium serum-low (hypomagnesemia)  1  5/95 (5.26%)  7
Phosphate serum-low (hypophosphatemia)  1  21/95 (22.11%)  29
Potassium serum-high (hyperkalemia)  1  5/95 (5.26%)  5
Potassium serum-low (hypokalemia)  1  27/95 (28.42%)  36
Sodium serum-high (hypernatremia)  1  2/95 (2.11%)  2
Sodium serum-low (hyponatremia)  1  21/95 (22.11%)  29
Uric acid serum-high (hyperuricemia)  1  4/95 (4.21%)  4
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic)  1  1/95 (1.05%)  1
Muscle weakness, generalized or specific area (not due to neuropathy)  1  7/95 (7.37%)  7
Myositis (inflammation/damage of muscle)  1  1/95 (1.05%)  1
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/95 (1.05%)  1
Dizziness  1  12/95 (12.63%)  12
Hemorrhage CNS  1  1/95 (1.05%)  1
Mental status  1  1/95 (1.05%)  1
Neurology - Other (Specify __)  1  1/95 (1.05%)  1
Neuropathy: motor  1  3/95 (3.16%)  3
Neuropathy: sensory  1  21/95 (22.11%)  36
Pain  1  26/95 (27.37%)  70
Somnolence/depressed level of consciousness  1  1/95 (1.05%)  1
Syncope (fainting)  1  1/95 (1.05%)  1
Taste alteration (dysgeusia)  1  4/95 (4.21%)  5
Tremor  1  1/95 (1.05%)  1
Vasovagal episode  1  1/95 (1.05%)  1
Psychiatric disorders   
Confusion  1  3/95 (3.16%)  3
Insomnia  1  9/95 (9.47%)  12
Mood alteration  1  11/95 (11.58%)  16
Psychosis (hallucinations/delusions)  1  2/95 (2.11%)  2
Renal and urinary disorders   
Hemorrhage GU  1  1/95 (1.05%)  1
Obstruction, GU  1  1/95 (1.05%)  1
Proteinuria  1  1/95 (1.05%)  1
Renal failure  1  1/95 (1.05%)  1
Urinary retention (including neurogenic bladder)  1  1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)  1  1/95 (1.05%)  1
Apnea  1  1/95 (1.05%)  1
Atelectasis  1  1/95 (1.05%)  1
Cough  1  7/95 (7.37%)  9
Dyspnea (shortness of breath)  1  14/95 (14.74%)  16
Hemorrhage pulmonary/upper respiratory  1  9/95 (9.47%)  9
Hiccoughs (hiccups singultus)  1  1/95 (1.05%)  1
Hypoxia  1  8/95 (8.42%)  9
Nasal cavity/paranasal sinus reactions  1  2/95 (2.11%)  3
Pleural effusion (non-malignant)  1  5/95 (5.26%)  5
Pneumonitis/pulmonary infiltrates  1  2/95 (2.11%)  2
Pulmonary/Upper Respiratory - Other (Specify __)  1  4/95 (4.21%)  4
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify __)  1  4/95 (4.21%)  5
Dry skin  1  2/95 (2.11%)  4
Hair loss/alopecia (scalp or body)  1  3/95 (3.16%)  3
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  5/95 (5.26%)  6
Pruritus/itching  1  8/95 (8.42%)  9
Rash/desquamation  1  53/95 (55.79%)  68
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  1/95 (1.05%)  1
Skin breakdown/decubitus ulcer  1  1/95 (1.05%)  1
Sweating (diaphoresis)  1  6/95 (6.32%)  6
Urticaria (hives welts wheals)  1  1/95 (1.05%)  1
Vascular disorders   
Hematoma  1  1/95 (1.05%)  1
Hemorrhage/Bleeding - Other (Specify __)  1  1/95 (1.05%)  1
Hypertension  1  16/95 (16.84%)  19
Hypotension  1  28/95 (29.47%)  40
Thrombosis/thrombus/embolism  1  1/95 (1.05%)  1
Vascular - Other (Specify __)  1  1/95 (1.05%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
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
Layout table for Results Point of Contact information
Name/Title: Eyal Attar, MD
Organization: Massachusetts General Hospital Cancer Center
Phone: 617-724-1124
EMail: eattar@partners.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00742625     History of Changes
Obsolete Identifiers: NCT01647061
Other Study ID Numbers: NCI-2009-00443
NCI-2009-00443 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000612758
CALGB 10502 ( Other Identifier: Cancer and Leukemia Group B )
CALGB-10502 ( Other Identifier: CTEP )
U10CA031946 ( U.S. NIH Grant/Contract )
P30CA014236 ( U.S. NIH Grant/Contract )
First Submitted: August 27, 2008
First Posted: August 28, 2008
Results First Submitted: January 2, 2013
Results First Posted: February 5, 2013
Last Update Posted: September 12, 2014