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Trial record 26 of 83 for:    "Adult Acute Lymphocytic Leukemia" | "Antineoplastic Agents, Hormonal"

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic 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: NCT01256398
Recruitment Status : Active, not recruiting
First Posted : December 8, 2010
Results First Posted : May 21, 2019
Last Update Posted : September 6, 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 Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Untreated Adult Acute Lymphoblastic Leukemia
Interventions Biological: Alemtuzumab
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide Phosphate
Biological: Filgrastim
Drug: Fludarabine Phosphate
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Mercaptopurine
Drug: Methotrexate
Biological: Pegfilgrastim
Other: Pharmacological Study
Drug: Tacrolimus
Drug: Vincristine Sulfate
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy, Transplant)
Hide Arm/Group Description

All enrolled patients. >

> Alemtuzumab: Given IV > Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT > Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT > Cyclophosphamide: Given IV > Cytarabine: Given IV > Dasatinib: Given PO > Daunorubicin Hydrochloride: Given IV > Dexamethasone: Given PO or IV > Etoposide Phosphate: Given IV > Filgrastim: Given SC > Fludarabine Phosphate: Given IV > In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT > Laboratory Biomarker Analysis: Correlative studies > Leucovorin Calcium: Given IV or PO > Melphalan: Given IV > Mercaptopurine: Given PO > Methotrexate: Given IT, IV, or PO > Pegfilgrastim: Given SC > Pharmacological Study: Correlative studies > Tacrolimus: Given IV or PO > Vincristine Sulfate: Given IV

Period Title: Overall Study
Started 66
Completed 65
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment (Chemotherapy, Transplant)
Hide Arm/Group Description

All enrolled patients. >

> Alemtuzumab: Given IV > Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT > Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT > Cyclophosphamide: Given IV > Cytarabine: Given IV > Dasatinib: Given PO > Daunorubicin Hydrochloride: Given IV > Dexamethasone: Given PO or IV > Etoposide Phosphate: Given IV > Filgrastim: Given SC > Fludarabine Phosphate: Given IV > In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT > Laboratory Biomarker Analysis: Correlative studies > Leucovorin Calcium: Given IV or PO > Melphalan: Given IV > Mercaptopurine: Given PO > Methotrexate: Given IT, IV, or PO > Pegfilgrastim: Given SC > Pharmacological Study: Correlative studies > Tacrolimus: Given IV or PO > Vincristine Sulfate: Given IV

Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
All patients that began treatment.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 65 participants
60.1
(51.2 to 67.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
33
  50.8%
Male
32
  49.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Hispanic or Latino
10
  15.4%
Not Hispanic or Latino
50
  76.9%
Unknown or Not Reported
5
   7.7%
1.Primary Outcome
Title Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
Hide Description Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
Time Frame At 3 years after CR
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that reached CR and chose to continue with the study.
Arm/Group Title Treatment (Chemotherapy, Transplant)
Hide Arm/Group Description:

All enrolled patients that reached CR during induction and continued to course 5. >

> Alemtuzumab: Given IV > Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT > Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT > Cyclophosphamide: Given IV > Cytarabine: Given IV > Dasatinib: Given PO > Daunorubicin Hydrochloride: Given IV > Dexamethasone: Given PO or IV > Etoposide Phosphate: Given IV > Filgrastim: Given SC > Fludarabine Phosphate: Given IV > In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT > Laboratory Biomarker Analysis: Correlative studies > Leucovorin Calcium: Given IV or PO > Melphalan: Given IV > Mercaptopurine: Given PO > Methotrexate: Given IT, IV, or PO > Pegfilgrastim: Given SC > Pharmacological Study: Correlative studies > Tacrolimus: Given IV or PO > Vincristine Sulfate: Given IV

Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
52.6
(36.8 to 68.5)
2.Secondary Outcome
Title Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)
Hide Description Proportions will be estimated based on the combined and individual cohorts.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR)
Hide Description Proportions will be estimated based on the combined and individual cohorts.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title OS
Hide Description Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title DFS
Hide Description Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
Time Frame From the date of first induction CR to relapse, or death due to any cause, with patients last known to be alive and disease-free censored at the date of last contact, assessed up to 10 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Response
Hide Description [Not Specified]
Time Frame Up to 10 years
Outcome Measure Data Not Reported
Time Frame 4 years
Adverse Event Reporting Description This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
 
Arm/Group Title Treatment (Chemotherapy, Transplant)
Hide Arm/Group Description Vincristine Sulfate: Given IV
All-Cause Mortality
Treatment (Chemotherapy, Transplant)
Affected / at Risk (%)
Total   5/65 (7.69%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemotherapy, Transplant)
Affected / at Risk (%) # Events
Total   5/65 (7.69%)    
General disorders   
Multi-organ failure  1  1/65 (1.54%)  1
Infections and infestations   
Lung infection  1  1/65 (1.54%)  1
Sepsis  1  1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Treatment related secondary malignancy  1  1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/65 (1.54%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Chemotherapy, Transplant)
Affected / at Risk (%) # Events
Total   65/65 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  59/65 (90.77%)  535
Blood and lymphatic system disorders - Other, specify  1  4/65 (6.15%)  5
Disseminated intravascular coagulation  1  10/65 (15.38%)  18
Febrile neutropenia  1  27/65 (41.54%)  41
Hemolysis  1  1/65 (1.54%)  1
Leukocytosis  1  6/65 (9.23%)  6
Lymph node pain  1  1/65 (1.54%)  1
Thrombotic thrombocytopenic purpura  1  1/65 (1.54%)  1
Cardiac disorders   
Atrial fibrillation  1  4/65 (6.15%)  4
Cardiac disorders - Other, specify  1  6/65 (9.23%)  9
Chest pain - cardiac  1  5/65 (7.69%)  5
Heart failure  1  2/65 (3.08%)  2
Left ventricular systolic dysfunction  1  1/65 (1.54%)  1
Mitral valve disease  1  1/65 (1.54%)  1
Myocardial infarction  1  4/65 (6.15%)  4
Palpitations  1  6/65 (9.23%)  12
Pericardial effusion  1  3/65 (4.62%)  6
Pericarditis  1  1/65 (1.54%)  1
Pulmonary valve disease  1  1/65 (1.54%)  1
Sinus bradycardia  1  3/65 (4.62%)  3
Sinus tachycardia  1  14/65 (21.54%)  35
Supraventricular tachycardia  1  3/65 (4.62%)  8
Tricuspid valve disease  1  1/65 (1.54%)  1
Ventricular arrhythmia  1  2/65 (3.08%)  3
Ventricular tachycardia  1  2/65 (3.08%)  2
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify  1  1/65 (1.54%)  1
Ear pain  1  2/65 (3.08%)  2
External ear pain  1  1/65 (1.54%)  1
Tinnitus  1  1/65 (1.54%)  1
Vertigo  1  2/65 (3.08%)  2
Vestibular disorder  1  1/65 (1.54%)  1
Endocrine disorders   
Cushingoid  1  1/65 (1.54%)  1
Endocrine disorders - Other, specify  1  1/65 (1.54%)  1
Hyperthyroidism  1  1/65 (1.54%)  1
Hypothyroidism  1  4/65 (6.15%)  5
Eye disorders   
Blurred vision  1  11/65 (16.92%)  16
Conjunctivitis  1  1/65 (1.54%)  1
Dry eye  1  7/65 (10.77%)  10
Extraocular muscle paresis  1  1/65 (1.54%)  1
Eye disorders - Other, specify  1  3/65 (4.62%)  3
Eye pain  1  2/65 (3.08%)  2
Eyelid function disorder  1  1/65 (1.54%)  1
Floaters  1  2/65 (3.08%)  2
Photophobia  1  2/65 (3.08%)  5
Watering eyes  1  2/65 (3.08%)  3
Gastrointestinal disorders   
Abdominal distension  1  6/65 (9.23%)  9
Abdominal pain  1  26/65 (40.00%)  54
Anal fistula  1  1/65 (1.54%)  1
Anal hemorrhage  1  3/65 (4.62%)  3
Anal pain  1  2/65 (3.08%)  4
Ascites  1  2/65 (3.08%)  2
Bloating  1  5/65 (7.69%)  9
Colitis  1  6/65 (9.23%)  9
Colonic hemorrhage  1  1/65 (1.54%)  1
Colonic perforation  1  2/65 (3.08%)  2
Constipation  1  37/65 (56.92%)  71
Diarrhea  1  47/65 (72.31%)  182
Dry mouth  1  8/65 (12.31%)  16
Dyspepsia  1  13/65 (20.00%)  16
Dysphagia  1  8/65 (12.31%)  11
Esophageal pain  1  1/65 (1.54%)  1
Esophagitis  1  4/65 (6.15%)  6
Flatulence  1  3/65 (4.62%)  5
Gastric hemorrhage  1  2/65 (3.08%)  2
Gastric ulcer  1  1/65 (1.54%)  1
Gastritis  1  3/65 (4.62%)  3
Gastroesophageal reflux disease  1  13/65 (20.00%)  22
Gastrointestinal disorders - Other, specify  1  12/65 (18.46%)  19
Hemorrhoidal hemorrhage  1  3/65 (4.62%)  3
Hemorrhoids  1  3/65 (4.62%)  3
Ileus  1  1/65 (1.54%)  2
Lower gastrointestinal hemorrhage  1  2/65 (3.08%)  8
Mucositis oral  1  30/65 (46.15%)  39
Nausea  1  47/65 (72.31%)  199
Oral pain  1  2/65 (3.08%)  2
Rectal hemorrhage  1  1/65 (1.54%)  3
Rectal pain  1  3/65 (4.62%)  3
Small intestinal mucositis  1  1/65 (1.54%)  1
Stomach pain  1  5/65 (7.69%)  6
Toothache  1  1/65 (1.54%)  1
Upper gastrointestinal hemorrhage  1  1/65 (1.54%)  1
Vomiting  1  40/65 (61.54%)  106
General disorders   
Chills  1  20/65 (30.77%)  31
Edema face  1  2/65 (3.08%)  2
Edema limbs  1  31/65 (47.69%)  98
Facial pain  1  1/65 (1.54%)  1
Fatigue  1  59/65 (90.77%)  318
Fever  1  28/65 (43.08%)  62
Gait disturbance  1  3/65 (4.62%)  6
General disorders and administration site conditions - Other, specify  1  7/65 (10.77%)  10
Infusion related reaction  1  4/65 (6.15%)  4
Injection site reaction  1  1/65 (1.54%)  1
Localized edema  1  4/65 (6.15%)  5
Malaise  1  6/65 (9.23%)  17
Multi-organ failure  1  2/65 (3.08%)  2
Neck edema  1  1/65 (1.54%)  1
Non-cardiac chest pain  1  11/65 (16.92%)  14
Pain  1  16/65 (24.62%)  42
Immune system disorders   
Allergic reaction  1  2/65 (3.08%)  2
Infections and infestations   
Appendicitis  1  1/65 (1.54%)  1
Bladder infection  1  1/65 (1.54%)  1
Bronchial infection  1  3/65 (4.62%)  3
Catheter related infection  1  7/65 (10.77%)  10
Enterocolitis infectious  1  6/65 (9.23%)  14
Hepatic infection  1  1/65 (1.54%)  1
Infections and infestations - Other, specify  1  18/65 (27.69%)  31
Infective myositis  1  1/65 (1.54%)  1
Joint infection  1  1/65 (1.54%)  5
Lip infection  1  1/65 (1.54%)  1
Lung infection  1  14/65 (21.54%)  33
Mucosal infection  1  6/65 (9.23%)  9
Otitis media  1  1/65 (1.54%)  1
Papulopustular rash  1  1/65 (1.54%)  2
Phlebitis infective  1  1/65 (1.54%)  1
Prostate infection  1  1/65 (1.54%)  1
Rash pustular  1  3/65 (4.62%)  3
Salivary gland infection  1  1/65 (1.54%)  1
Sepsis  1  5/65 (7.69%)  7
Sinusitis  1  11/65 (16.92%)  15
Skin infection  1  7/65 (10.77%)  18
Soft tissue infection  1  2/65 (3.08%)  2
Tooth infection  1  1/65 (1.54%)  1
Upper respiratory infection  1  18/65 (27.69%)  28
Urinary tract infection  1  14/65 (21.54%)  30
Vaginal infection  1  2/65 (3.08%)  2
Wound infection  1  1/65 (1.54%)  2
Injury, poisoning and procedural complications   
Ankle fracture  1  1/65 (1.54%)  1
Bruising  1  13/65 (20.00%)  24
Fall  1  8/65 (12.31%)  11
Fracture  1  2/65 (3.08%)  2
Postoperative hemorrhage  1  3/65 (4.62%)  3
Wound dehiscence  1  1/65 (1.54%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  12/65 (18.46%)  16
Alanine aminotransferase increased  1  48/65 (73.85%)  204
Alkaline phosphatase increased  1  37/65 (56.92%)  149
Aspartate aminotransferase increased  1  45/65 (69.23%)  216
Blood bilirubin increased  1  23/65 (35.38%)  37
Cardiac troponin I increased  1  5/65 (7.69%)  6
Cholesterol high  1  1/65 (1.54%)  1
Creatinine increased  1  28/65 (43.08%)  116
Electrocardiogram QT corrected interval prolonged  1  8/65 (12.31%)  17
Fibrinogen decreased  1  10/65 (15.38%)  10
Haptoglobin decreased  1  2/65 (3.08%)  2
INR increased  1  16/65 (24.62%)  22
Investigations - Other, specify  1  8/65 (12.31%)  32
Lymphocyte count decreased  1  41/65 (63.08%)  212
Lymphocyte count increased  1  4/65 (6.15%)  4
Neutrophil count decreased  1  61/65 (93.85%)  342
Platelet count decreased  1  63/65 (96.92%)  413
Serum amylase increased  1  1/65 (1.54%)  1
Weight gain  1  5/65 (7.69%)  5
Weight loss  1  11/65 (16.92%)  121
White blood cell decreased  1  54/65 (83.08%)  284
Metabolism and nutrition disorders   
Acidosis  1  4/65 (6.15%)  4
Alkalosis  1  1/65 (1.54%)  1
Anorexia  1  33/65 (50.77%)  98
Dehydration  1  10/65 (15.38%)  13
Hypercalcemia  1  6/65 (9.23%)  11
Hyperglycemia  1  51/65 (78.46%)  284
Hyperkalemia  1  17/65 (26.15%)  37
Hypermagnesemia  1  21/65 (32.31%)  32
Hypernatremia  1  15/65 (23.08%)  25
Hypertriglyceridemia  1  7/65 (10.77%)  16
Hyperuricemia  1  11/65 (16.92%)  53
Hypoalbuminemia  1  44/65 (67.69%)  189
Hypocalcemia  1  45/65 (69.23%)  129
Hypoglycemia  1  11/65 (16.92%)  27
Hypokalemia  1  46/65 (70.77%)  151
Hypomagnesemia  1  28/65 (43.08%)  80
Hyponatremia  1  38/65 (58.46%)  122
Hypophosphatemia  1  29/65 (44.62%)  61
Metabolism and nutrition disorders - Other, specify  1  3/65 (4.62%)  29
Tumor lysis syndrome  1  6/65 (9.23%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  21/65 (32.31%)  34
Arthritis  1  1/65 (1.54%)  2
Back pain  1  28/65 (43.08%)  51
Bone pain  1  7/65 (10.77%)  8
Buttock pain  1  1/65 (1.54%)  1
Chest wall pain  1  2/65 (3.08%)  3
Flank pain  1  1/65 (1.54%)  1
Generalized muscle weakness  1  14/65 (21.54%)  35
Joint effusion  1  1/65 (1.54%)  1
Joint range of motion decreased  1  1/65 (1.54%)  1
Muscle weakness lower limb  1  4/65 (6.15%)  6
Musculoskeletal and connective tissue disorder - Other, specify  1  4/65 (6.15%)  5
Myalgia  1  11/65 (16.92%)  15
Neck pain  1  9/65 (13.85%)  17
Pain in extremity  1  16/65 (24.62%)  38
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  2/65 (3.08%)  2
Nervous system disorders   
Ataxia  1  1/65 (1.54%)  1
Depressed level of consciousness  1  1/65 (1.54%)  1
Dizziness  1  22/65 (33.85%)  43
Dysgeusia  1  8/65 (12.31%)  14
Dysphasia  1  1/65 (1.54%)  1
Facial muscle weakness  1  1/65 (1.54%)  1
Headache  1  32/65 (49.23%)  86
Hypersomnia  1  1/65 (1.54%)  2
Intracranial hemorrhage  1  1/65 (1.54%)  1
Lethargy  1  5/65 (7.69%)  6
Memory impairment  1  1/65 (1.54%)  1
Movements involuntary  1  1/65 (1.54%)  1
Nervous system disorders - Other, specify  1  4/65 (6.15%)  7
Neuralgia  1  1/65 (1.54%)  1
Paresthesia  1  1/65 (1.54%)  1
Peripheral motor neuropathy  1  7/65 (10.77%)  9
Peripheral sensory neuropathy  1  25/65 (38.46%)  118
Phantom pain  1  1/65 (1.54%)  1
Presyncope  1  1/65 (1.54%)  1
Reversible posterior leukoencephalopathy syndrome  1  1/65 (1.54%)  1
Sinus pain  1  1/65 (1.54%)  1
Somnolence  1  3/65 (4.62%)  5
Syncope  1  3/65 (4.62%)  3
Tremor  1  7/65 (10.77%)  7
Psychiatric disorders   
Agitation  1  1/65 (1.54%)  1
Anxiety  1  20/65 (30.77%)  56
Confusion  1  6/65 (9.23%)  9
Delirium  1  1/65 (1.54%)  2
Delusions  1  1/65 (1.54%)  1
Depression  1  11/65 (16.92%)  34
Hallucinations  1  4/65 (6.15%)  6
Insomnia  1  28/65 (43.08%)  51
Libido decreased  1  1/65 (1.54%)  1
Libido increased  1  1/65 (1.54%)  1
Psychiatric disorders - Other, specify  1  2/65 (3.08%)  2
Restlessness  1  2/65 (3.08%)  2
Renal and urinary disorders   
Acute kidney injury  1  13/65 (20.00%)  39
Bladder spasm  1  1/65 (1.54%)  3
Chronic kidney disease  1  8/65 (12.31%)  36
Cystitis noninfective  1  1/65 (1.54%)  1
Hematuria  1  6/65 (9.23%)  10
Proteinuria  1  13/65 (20.00%)  19
Renal and urinary disorders - Other, specify  1  8/65 (12.31%)  10
Urinary frequency  1  9/65 (13.85%)  11
Urinary incontinence  1  3/65 (4.62%)  6
Urinary retention  1  3/65 (4.62%)  4
Urinary tract pain  1  3/65 (4.62%)  7
Urinary urgency  1  3/65 (4.62%)  3
Reproductive system and breast disorders   
Testicular pain  1  1/65 (1.54%)  1
Uterine pain  1  2/65 (3.08%)  2
Vaginal hemorrhage  1  3/65 (4.62%)  6
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  7/65 (10.77%)  13
Atelectasis  1  7/65 (10.77%)  7
Bronchopulmonary hemorrhage  1  2/65 (3.08%)  2
Cough  1  33/65 (50.77%)  72
Dyspnea  1  35/65 (53.85%)  118
Epistaxis  1  7/65 (10.77%)  7
Hiccups  1  4/65 (6.15%)  4
Hoarseness  1  2/65 (3.08%)  2
Hypoxia  1  7/65 (10.77%)  7
Laryngeal hemorrhage  1  1/65 (1.54%)  1
Nasal congestion  1  12/65 (18.46%)  20
Pharyngeal mucositis  1  1/65 (1.54%)  1
Pharyngolaryngeal pain  1  1/65 (1.54%)  1
Pleural effusion  1  26/65 (40.00%)  60
Pleuritic pain  1  1/65 (1.54%)  1
Pneumonitis  1  2/65 (3.08%)  2
Postnasal drip  1  4/65 (6.15%)  7
Productive cough  1  8/65 (12.31%)  12
Pulmonary edema  1  6/65 (9.23%)  6
Pulmonary hypertension  1  1/65 (1.54%)  1
Respiratory failure  1  2/65 (3.08%)  2
Respiratory, thoracic and mediastinal disorders - Other, specify  1  6/65 (9.23%)  10
Sleep apnea  1  1/65 (1.54%)  1
Sore throat  1  18/65 (27.69%)  23
Wheezing  1  7/65 (10.77%)  7
Skin and subcutaneous tissue disorders   
Alopecia  1  7/65 (10.77%)  12
Bullous dermatitis  1  1/65 (1.54%)  1
Dry skin  1  14/65 (21.54%)  36
Erythema multiforme  1  3/65 (4.62%)  3
Nail loss  1  1/65 (1.54%)  1
Pain of skin  1  1/65 (1.54%)  1
Palmar-plantar erythrodysesthesia syndrome  1  1/65 (1.54%)  1
Periorbital edema  1  2/65 (3.08%)  6
Pruritus  1  19/65 (29.23%)  30
Purpura  1  6/65 (9.23%)  12
Rash acneiform  1  5/65 (7.69%)  12
Rash maculo-papular  1  34/65 (52.31%)  79
Scalp pain  1  1/65 (1.54%)  1
Skin and subcutaneous tissue disorders - Other, specify  1  16/65 (24.62%)  56
Skin induration  1  2/65 (3.08%)  6
Skin ulceration  1  3/65 (4.62%)  3
Urticaria  1  7/65 (10.77%)  11
Surgical and medical procedures   
Surgical and medical procedures - Other, specify  1  1/65 (1.54%)  1
Vascular disorders   
Flushing  1  5/65 (7.69%)  6
Hematoma  1  6/65 (9.23%)  8
Hot flashes  1  7/65 (10.77%)  15
Hypertension  1  21/65 (32.31%)  68
Hypotension  1  16/65 (24.62%)  27
Superficial thrombophlebitis  1  2/65 (3.08%)  2
Thromboembolic event  1  7/65 (10.77%)  13
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
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: Matthew Wieduwilt, MD, PhD
Organization: University of California San Diego Moores Cancer Center
Phone: 858-822-6848
EMail: mwieduwilt@ucsd.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01256398     History of Changes
Other Study ID Numbers: NCI-2011-02621
NCI-2011-02621 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB 10701/CTSU C10701
CDR0000690286
CALGB-10701 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-10701 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: February 4, 2019
Results First Posted: May 21, 2019
Last Update Posted: September 6, 2019