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Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01253070
Recruitment Status : Active, not recruiting
First Posted : December 3, 2010
Results First Posted : February 11, 2016
Last Update Posted : October 22, 2019
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 With FLT3/ITD Mutation
Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Acute Promyelocytic Leukemia With PML-RARA
FLT3 Gene Mutation
Therapy-Related Acute Myeloid Leukemia
Interventions Procedure: Biopsy
Procedure: Bone Marrow Aspiration
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Sorafenib Tosylate
Enrollment 54
Recruitment Details A total of 54 participants were recruited from April 2011 to August 2013.
Pre-assignment Details  
Arm/Group Title Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Hide Arm/Group Description

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

Period Title: Overall Study
Started 54
Completed 54
Not Completed 0
Arm/Group Title Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Hide Arm/Group Description

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 54 participants
67.4
(60.3 to 82.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
24
  44.4%
Male
30
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Hispanic or Latino
2
   3.7%
Not Hispanic or Latino
47
  87.0%
Unknown or Not Reported
5
   9.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.9%
White
51
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
2
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
FLT3 Mutation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
ITD 39
TKD 15
[1]
Measure Description: FLT3 (FMS-like tyrosine kinase-3) mutation testing at baseline was performed centrally for all patients. Participants were eligible for the study if they had an ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation.
1.Primary Outcome
Title Overall Survival (OS) Rate
Hide Description Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants withdrew consent to protocol treatment and follow-up prior to 1 year post registration (2 ITD; 1 TKD). These participants have been excluded from the primary endpoint analysis.
Arm/Group Title ITD Mutated Participants TKD Mutated Participants
Hide Arm/Group Description:

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

Overall Number of Participants Analyzed 37 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62
(45 to 78)
71
(42 to 92)
2.Secondary Outcome
Title OS
Hide Description OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Time Frame Time from registration to death (up to 10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITD Mutated Participants TKD Mutated Participants
Hide Arm/Group Description:

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

Overall Number of Participants Analyzed 39 15
Median (95% Confidence Interval)
Unit of Measure: months
15
(10.4 to 20.1)
16.2 [1] 
(5.0 to NA)
[1]
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
3.Secondary Outcome
Title Event-free Survival
Hide Description Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Time from registration to death or relapse (up to 10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITD Mutated Participants TKD Mutated Participants
Hide Arm/Group Description:

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

Overall Number of Participants Analyzed 39 15
Median (95% Confidence Interval)
Unit of Measure: months
8.8
(3.0 to 13.9)
7.8
(1.3 to 11.6)
Time Frame [Not Specified]
Adverse Event Reporting Description At the time of analysis, adverse event data was collected on 50 of 54 participants.
 
Arm/Group Title Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Hide Arm/Group Description

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

All-Cause Mortality
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Affected / at Risk (%) # Events
Total   21/50 (42.00%)    
Blood and lymphatic system disorders   
Anemia  1  20/50 (40.00%)  24
Blood and lymphatic system disorders - Other  1  2/50 (4.00%)  2
Disseminated intravascular coagulation  1  2/50 (4.00%)  2
Febrile neutropenia  1  13/50 (26.00%)  15
Leukocytosis  1  1/50 (2.00%)  1
Cardiac disorders   
Atrial fibrillation  1  5/50 (10.00%)  5
Atrial flutter  1  1/50 (2.00%)  1
Atrioventricular block first degree  1  1/50 (2.00%)  1
Cardiac arrest  1  2/50 (4.00%)  2
Cardiac disorders - Other  1  1/50 (2.00%)  1
Chest pain - cardiac  1  1/50 (2.00%)  1
Heart failure  1  2/50 (4.00%)  2
Left ventricular systolic dysfunction  1  3/50 (6.00%)  3
Pericarditis  1  1/50 (2.00%)  1
Sinus bradycardia  1  2/50 (4.00%)  2
Sinus tachycardia  1  4/50 (8.00%)  4
Supraventricular tachycardia  1  2/50 (4.00%)  2
Ventricular arrhythmia  1  2/50 (4.00%)  2
Ventricular tachycardia  1  1/50 (2.00%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/50 (2.00%)  1
Endocrine disorders   
Hypothyroidism  1  1/50 (2.00%)  1
Eye disorders   
Blurred vision  1  2/50 (4.00%)  2
Dry eye  1  1/50 (2.00%)  1
Eye disorders - Other  1  1/50 (2.00%)  1
Gastrointestinal disorders   
Abdominal pain  1  6/50 (12.00%)  6
Constipation  1  4/50 (8.00%)  4
Diarrhea  1  14/50 (28.00%)  14
Gastrointestinal disorders - Other  1  2/50 (4.00%)  2
Mucositis oral  1  7/50 (14.00%)  7
Nausea  1  7/50 (14.00%)  9
Oral hemorrhage  1  1/50 (2.00%)  1
Oral pain  1  1/50 (2.00%)  1
Rectal hemorrhage  1  1/50 (2.00%)  1
Rectal pain  1  1/50 (2.00%)  1
Small intestinal obstruction  1  1/50 (2.00%)  1
Vomiting  1  3/50 (6.00%)  5
General disorders   
Chills  1  1/50 (2.00%)  1
Edema limbs  1  7/50 (14.00%)  9
Fatigue  1  11/50 (22.00%)  13
Fever  1  1/50 (2.00%)  1
Localized edema  1  1/50 (2.00%)  1
Multi-organ failure  1  1/50 (2.00%)  1
Non-cardiac chest pain  1  1/50 (2.00%)  1
Pain  1  2/50 (4.00%)  7
Immune system disorders   
Allergic reaction  1  1/50 (2.00%)  2
Infections and infestations   
Bone infection  1  1/50 (2.00%)  2
Enterocolitis infectious  1  1/50 (2.00%)  1
Infections and infestations - Other  1  1/50 (2.00%)  1
Laryngitis  1  1/50 (2.00%)  1
Lip infection  1  1/50 (2.00%)  1
Lung infection  1  8/50 (16.00%)  10
Sepsis  1  6/50 (12.00%)  7
Urinary tract infection  1  4/50 (8.00%)  4
Injury, poisoning and procedural complications   
Bruising  1  1/50 (2.00%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  3/50 (6.00%)  3
Alanine aminotransferase increased  1  8/50 (16.00%)  8
Alkaline phosphatase increased  1  6/50 (12.00%)  7
Aspartate aminotransferase increased  1  11/50 (22.00%)  11
Blood bilirubin increased  1  8/50 (16.00%)  8
Creatinine increased  1  5/50 (10.00%)  5
Ejection fraction decreased  1  2/50 (4.00%)  2
Electrocardiogram QT corrected interval prolonged  1  1/50 (2.00%)  1
INR increased  1  4/50 (8.00%)  6
Investigations - Other  1  2/50 (4.00%)  4
Lymphocyte count decreased  1  8/50 (16.00%)  10
Neutrophil count decreased  1  19/50 (38.00%)  22
Platelet count decreased  1  20/50 (40.00%)  23
Urine output decreased  1  1/50 (2.00%)  1
Weight gain  1  1/50 (2.00%)  1
Weight loss  1  2/50 (4.00%)  2
White blood cell decreased  1  14/50 (28.00%)  15
Metabolism and nutrition disorders   
Acidosis  1  3/50 (6.00%)  3
Alkalosis  1  1/50 (2.00%)  1
Anorexia  1  8/50 (16.00%)  9
Hypercalcemia  1  3/50 (6.00%)  3
Hyperglycemia  1  11/50 (22.00%)  11
Hyperkalemia  1  3/50 (6.00%)  3
Hypermagnesemia  1  2/50 (4.00%)  2
Hypernatremia  1  2/50 (4.00%)  2
Hyperuricemia  1  2/50 (4.00%)  3
Hypoalbuminemia  1  13/50 (26.00%)  16
Hypocalcemia  1  11/50 (22.00%)  11
Hypoglycemia  1  2/50 (4.00%)  2
Hypokalemia  1  10/50 (20.00%)  10
Hypomagnesemia  1  5/50 (10.00%)  5
Hyponatremia  1  11/50 (22.00%)  13
Hypophosphatemia  1  8/50 (16.00%)  11
Metabolism and nutrition disorders - Other  1  1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  4/50 (8.00%)  6
Chest wall pain  1  1/50 (2.00%)  1
Flank pain  1  1/50 (2.00%)  1
Generalized muscle weakness  1  5/50 (10.00%)  5
Muscle weakness right-sided  1  2/50 (4.00%)  2
Osteoporosis  1  1/50 (2.00%)  1
Pain in extremity  1  1/50 (2.00%)  1
Nervous system disorders   
Ataxia  1  1/50 (2.00%)  1
Depressed level of consciousness  1  1/50 (2.00%)  1
Dizziness  1  1/50 (2.00%)  1
Dysarthria  1  1/50 (2.00%)  1
Headache  1  2/50 (4.00%)  2
Lethargy  1  1/50 (2.00%)  1
Nervous system disorders - Other  1  1/50 (2.00%)  1
Peripheral sensory neuropathy  1  1/50 (2.00%)  1
Reversible posterior leukoencephalopathy syndrome  1  1/50 (2.00%)  1
Seizure  1  1/50 (2.00%)  1
Transient ischemic attacks  1  1/50 (2.00%)  1
Psychiatric disorders   
Anxiety  1  2/50 (4.00%)  2
Confusion  1  4/50 (8.00%)  4
Insomnia  1  2/50 (4.00%)  2
Renal and urinary disorders   
Acute kidney injury  1  3/50 (6.00%)  3
Chronic kidney disease  1  1/50 (2.00%)  1
Hematuria  1  3/50 (6.00%)  3
Proteinuria  1  2/50 (4.00%)  2
Renal calculi  1  1/50 (2.00%)  1
Urinary incontinence  1  2/50 (4.00%)  2
Urinary retention  1  1/50 (2.00%)  1
Urinary tract pain  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  1/50 (2.00%)  1
Cough  1  4/50 (8.00%)  4
Dyspnea  1  5/50 (10.00%)  5
Hiccups  1  1/50 (2.00%)  1
Hypoxia  1  3/50 (6.00%)  3
Nasal congestion  1  1/50 (2.00%)  1
Pleural effusion  1  3/50 (6.00%)  3
Pulmonary edema  1  4/50 (8.00%)  4
Pulmonary hypertension  1  1/50 (2.00%)  1
Respiratory failure  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders - Other  1  2/50 (4.00%)  2
Sore throat  1  1/50 (2.00%)  1
Wheezing  1  2/50 (4.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  1/50 (2.00%)  1
Dry skin  1  1/50 (2.00%)  1
Erythema multiforme  1  2/50 (4.00%)  2
Hyperhidrosis  1  1/50 (2.00%)  1
Pain of skin  1  1/50 (2.00%)  1
Palmar-plantar erythrodysesthesia syndrome  1  1/50 (2.00%)  1
Pruritus  1  3/50 (6.00%)  3
Rash maculo-papular  1  10/50 (20.00%)  13
Skin and subcutaneous tissue disorders - Other  1  2/50 (4.00%)  3
Skin induration  1  1/50 (2.00%)  1
Skin ulceration  1  1/50 (2.00%)  1
Vascular disorders   
Hematoma  1  1/50 (2.00%)  1
Hypertension  1  4/50 (8.00%)  4
Hypotension  1  5/50 (10.00%)  6
Thromboembolic event  1  2/50 (4.00%)  3
Vascular disorders - Other  1  2/50 (4.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Affected / at Risk (%) # Events
Total   42/50 (84.00%)    
Blood and lymphatic system disorders   
Anemia  1  41/50 (82.00%)  134
Blood and lymphatic system disorders - Other  1  1/50 (2.00%)  7
Disseminated intravascular coagulation  1  5/50 (10.00%)  6
Febrile neutropenia  1  27/50 (54.00%)  37
Lymph node pain  1  1/50 (2.00%)  1
Cardiac disorders   
Atrial fibrillation  1  3/50 (6.00%)  8
Chest pain - cardiac  1  1/50 (2.00%)  1
Mitral valve disease  1  1/50 (2.00%)  1
Palpitations  1  2/50 (4.00%)  2
Pericardial effusion  1  1/50 (2.00%)  1
Sinus bradycardia  1  6/50 (12.00%)  7
Sinus tachycardia  1  2/50 (4.00%)  3
Ventricular arrhythmia  1  1/50 (2.00%)  1
Ear and labyrinth disorders   
Ear pain  1  3/50 (6.00%)  3
Vertigo  1  1/50 (2.00%)  1
Endocrine disorders   
Hypothyroidism  1  3/50 (6.00%)  3
Eye disorders   
Blurred vision  1  4/50 (8.00%)  5
Conjunctivitis  1  2/50 (4.00%)  4
Dry eye  1  1/50 (2.00%)  1
Eye disorders - Other  1  2/50 (4.00%)  2
Vitreous hemorrhage  1  1/50 (2.00%)  1
Gastrointestinal disorders   
Abdominal distension  1  3/50 (6.00%)  3
Abdominal pain  1  13/50 (26.00%)  18
Anal ulcer  1  1/50 (2.00%)  1
Colitis  1  2/50 (4.00%)  3
Constipation  1  20/50 (40.00%)  25
Dental caries  1  1/50 (2.00%)  1
Diarrhea  1  35/50 (70.00%)  81
Dry mouth  1  4/50 (8.00%)  6
Dyspepsia  1  4/50 (8.00%)  5
Dysphagia  1  1/50 (2.00%)  1
Enterocolitis  1  1/50 (2.00%)  1
Esophagitis  1  1/50 (2.00%)  1
Flatulence  1  4/50 (8.00%)  8
Gastritis  1  2/50 (4.00%)  4
Gastroesophageal reflux disease  1  5/50 (10.00%)  7
Gastrointestinal disorders - Other  1  2/50 (4.00%)  2
Hemorrhoidal hemorrhage  1  2/50 (4.00%)  2
Hemorrhoids  1  6/50 (12.00%)  7
Lower gastrointestinal hemorrhage  1  1/50 (2.00%)  1
Mucositis oral  1  22/50 (44.00%)  31
Nausea  1  30/50 (60.00%)  58
Oral hemorrhage  1  3/50 (6.00%)  3
Oral pain  1  4/50 (8.00%)  5
Rectal pain  1  2/50 (4.00%)  3
Stomach pain  1  1/50 (2.00%)  1
Vomiting  1  12/50 (24.00%)  18
General disorders   
Chills  1  12/50 (24.00%)  14
Edema face  1  3/50 (6.00%)  3
Edema limbs  1  22/50 (44.00%)  37
Facial pain  1  1/50 (2.00%)  1
Fatigue  1  31/50 (62.00%)  77
Fever  1  12/50 (24.00%)  14
General disorders and administration site conditions - Other  1  2/50 (4.00%)  4
Infusion related reaction  1  2/50 (4.00%)  2
Malaise  1  3/50 (6.00%)  3
Non-cardiac chest pain  1  1/50 (2.00%)  1
Pain  1  8/50 (16.00%)  11
Hepatobiliary disorders   
Hepatobiliary disorders - Other  1  1/50 (2.00%)  1
Infections and infestations   
Bladder infection  1  1/50 (2.00%)  1
Bone infection  1  1/50 (2.00%)  2
Catheter related infection  1  5/50 (10.00%)  5
Infections and infestations - Other  1  8/50 (16.00%)  9
Lip infection  1  2/50 (4.00%)  2
Lung infection  1  3/50 (6.00%)  5
Pharyngitis  1  1/50 (2.00%)  1
Sepsis  1  3/50 (6.00%)  3
Sinusitis  1  2/50 (4.00%)  2
Skin infection  1  2/50 (4.00%)  2
Small intestine infection  1  1/50 (2.00%)  2
Upper respiratory infection  1  2/50 (4.00%)  2
Urinary tract infection  1  5/50 (10.00%)  6
Injury, poisoning and procedural complications   
Bruising  1  7/50 (14.00%)  7
Fall  1  4/50 (8.00%)  4
Investigations   
Activated partial thromboplastin time prolonged  1  7/50 (14.00%)  10
Alanine aminotransferase increased  1  26/50 (52.00%)  66
Alkaline phosphatase increased  1  17/50 (34.00%)  28
Aspartate aminotransferase increased  1  23/50 (46.00%)  52
Blood bilirubin increased  1  25/50 (50.00%)  49
Cholesterol high  1  2/50 (4.00%)  2
Creatinine increased  1  9/50 (18.00%)  19
Electrocardiogram QT corrected interval prolonged  1  1/50 (2.00%)  1
INR increased  1  11/50 (22.00%)  22
Investigations - Other  1  2/50 (4.00%)  4
Lipase increased  1  1/50 (2.00%)  1
Lymphocyte count decreased  1  21/50 (42.00%)  68
Neutrophil count decreased  1  42/50 (84.00%)  97
Platelet count decreased  1  42/50 (84.00%)  133
Serum amylase increased  1  1/50 (2.00%)  1
Weight loss  1  7/50 (14.00%)  11
White blood cell decreased  1  30/50 (60.00%)  71
Metabolism and nutrition disorders   
Anorexia  1  22/50 (44.00%)  38
Dehydration  1  3/50 (6.00%)  6
Hypercalcemia  1  4/50 (8.00%)  8
Hyperglycemia  1  27/50 (54.00%)  69
Hyperkalemia  1  5/50 (10.00%)  5
Hypermagnesemia  1  6/50 (12.00%)  6
Hypernatremia  1  2/50 (4.00%)  2
Hypertriglyceridemia  1  3/50 (6.00%)  3
Hyperuricemia  1  2/50 (4.00%)  3
Hypoalbuminemia  1  34/50 (68.00%)  67
Hypocalcemia  1  24/50 (48.00%)  36
Hypoglycemia  1  2/50 (4.00%)  3
Hypokalemia  1  24/50 (48.00%)  37
Hypomagnesemia  1  12/50 (24.00%)  20
Hyponatremia  1  24/50 (48.00%)  40
Hypophosphatemia  1  22/50 (44.00%)  31
Metabolism and nutrition disorders - Other  1  3/50 (6.00%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/50 (10.00%)  6
Back pain  1  5/50 (10.00%)  15
Bone pain  1  1/50 (2.00%)  6
Chest wall pain  1  1/50 (2.00%)  1
Generalized muscle weakness  1  7/50 (14.00%)  8
Joint effusion  1  1/50 (2.00%)  1
Muscle weakness right-sided  1  2/50 (4.00%)  2
Musculoskeletal and connective tissue disorder - Other  1  3/50 (6.00%)  4
Myalgia  1  3/50 (6.00%)  3
Neck pain  1  1/50 (2.00%)  1
Osteoporosis  1  1/50 (2.00%)  1
Pain in extremity  1  5/50 (10.00%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  1  1/50 (2.00%)  2
Nervous system disorders   
Dizziness  1  12/50 (24.00%)  15
Dysgeusia  1  3/50 (6.00%)  3
Headache  1  16/50 (32.00%)  20
Lethargy  1  1/50 (2.00%)  1
Memory impairment  1  1/50 (2.00%)  1
Nervous system disorders - Other  1  2/50 (4.00%)  2
Neuralgia  1  1/50 (2.00%)  1
Peripheral sensory neuropathy  1  3/50 (6.00%)  12
Phantom pain  1  1/50 (2.00%)  1
Sinus pain  1  1/50 (2.00%)  1
Syncope  1  1/50 (2.00%)  1
Transient ischemic attacks  1  2/50 (4.00%)  2
Tremor  1  2/50 (4.00%)  2
Psychiatric disorders   
Anxiety  1  9/50 (18.00%)  10
Confusion  1  3/50 (6.00%)  3
Depression  1  6/50 (12.00%)  6
Hallucinations  1  2/50 (4.00%)  2
Insomnia  1  9/50 (18.00%)  14
Personality change  1  1/50 (2.00%)  2
Renal and urinary disorders   
Acute kidney injury  1  1/50 (2.00%)  1
Chronic kidney disease  1  2/50 (4.00%)  2
Hematuria  1  4/50 (8.00%)  9
Proteinuria  1  3/50 (6.00%)  8
Renal and urinary disorders - Other  1  3/50 (6.00%)  10
Urinary frequency  1  5/50 (10.00%)  9
Urinary incontinence  1  2/50 (4.00%)  2
Reproductive system and breast disorders   
Vaginal hemorrhage  1  3/50 (6.00%)  3
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/50 (2.00%)  1
Atelectasis  1  2/50 (4.00%)  2
Cough  1  13/50 (26.00%)  21
Dyspnea  1  18/50 (36.00%)  25
Epistaxis  1  12/50 (24.00%)  14
Hiccups  1  1/50 (2.00%)  1
Hoarseness  1  1/50 (2.00%)  1
Hypoxia  1  2/50 (4.00%)  2
Laryngeal hemorrhage  1  1/50 (2.00%)  1
Nasal congestion  1  5/50 (10.00%)  6
Pharyngeal hemorrhage  1  1/50 (2.00%)  1
Pleural effusion  1  2/50 (4.00%)  2
Postnasal drip  1  1/50 (2.00%)  1
Productive cough  1  1/50 (2.00%)  1
Pulmonary edema  1  4/50 (8.00%)  4
Respiratory, thoracic and mediastinal disorders - Other  1  3/50 (6.00%)  9
Sore throat  1  3/50 (6.00%)  3
Wheezing  1  1/50 (2.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  8/50 (16.00%)  12
Bullous dermatitis  1  3/50 (6.00%)  4
Dry skin  1  8/50 (16.00%)  19
Erythema multiforme  1  4/50 (8.00%)  5
Hyperhidrosis  1  3/50 (6.00%)  5
Pain of skin  1  2/50 (4.00%)  3
Palmar-plantar erythrodysesthesia syndrome  1  9/50 (18.00%)  18
Periorbital edema  1  1/50 (2.00%)  1
Pruritus  1  8/50 (16.00%)  10
Purpura  1  3/50 (6.00%)  3
Rash acneiform  1  1/50 (2.00%)  2
Rash maculo-papular  1  30/50 (60.00%)  63
Scalp pain  1  1/50 (2.00%)  1
Skin and subcutaneous tissue disorders - Other  1  11/50 (22.00%)  26
Skin ulceration  1  2/50 (4.00%)  2
Urticaria  1  1/50 (2.00%)  1
Vascular disorders   
Flushing  1  1/50 (2.00%)  1
Hematoma  1  1/50 (2.00%)  1
Hot flashes  1  2/50 (4.00%)  5
Hypertension  1  17/50 (34.00%)  30
Hypotension  1  11/50 (22.00%)  13
Phlebitis  1  1/50 (2.00%)  1
Thromboembolic event  1  1/50 (2.00%)  2
Vascular disorders - Other  1  1/50 (2.00%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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: Geoffrey Uy, MD
Organization: Washington University School of Medicine
EMail: guy@dom.wustl.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01253070     History of Changes
Other Study ID Numbers: NCI-2011-02618
NCI-2011-02618 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000689593
CALGB-11001 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-11001 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: December 2, 2010
First Posted: December 3, 2010
Results First Submitted: January 13, 2016
Results First Posted: February 11, 2016
Last Update Posted: October 22, 2019