Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

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: NCT00720356
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Jeffrey Raizer, Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain and Central Nervous System Tumors
Interventions Drug: bevacizumab
Drug: erlotinib hydrochloride
Enrollment 115
Recruitment Details The study was ready for accrual March 12, 2009 with an accrual goal of up to 50 patients. The first patient was enrolled on July 7 2009. Accrual was suspended on July 29 2010 and reopened on March 30, 2011. The study was closed permanently on November 03, 2011 with an accrual of 48 patients treated on study after screening 115 patients.
Pre-assignment Details Registration is a two step process. ICF signed, tissue sent off and MGMT promoter methylation status determined eligibility. Patients with unmethylated MGMT promoters will be complete the second registration step and be treated on study. Patients with methylated MGMT promoters will not be treated on study.
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Period Title: Registration to Study
Started 115
Completed Registration Step 1 115
Completed Registration Step 2 48
Completed 48
Not Completed 67
Reason Not Completed
Determined to have methylated MGMT             67
Period Title: Reached 1st Response/2 Cycles
Started 48
Completed 46
Not Completed 2
Reason Not Completed
Progressive Disease             1
Withdrawal by Subject             1
Period Title: Went on to be Treated Cycle 3
Started 46
Completed 44
Not Completed 2
Reason Not Completed
Adverse Event             1
Physician Decision             1
Period Title: Follow up Until Death
Started 48 [1]
Completed 43
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
Alive at last data collection             4
[1]
All patients that are treated on study go into the follow up period
Arm/Group Title Treatment
Hide Arm/Group Description

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Baseline Participants 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
<=18 years
0
   0.0%
Between 18 and 65 years
82
  71.3%
>=65 years
33
  28.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
Female
45
  39.1%
Male
70
  60.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 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
3
   2.6%
White
109
  94.8%
More than one race
0
   0.0%
Unknown or Not Reported
3
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 115 participants
115
Methylated/unmethylated MGMT promoter   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
Methylated MGMT promoter
67
  58.3%
Unmethylated MGMT promoter
48
  41.7%
[1]
Measure Description: After registration step 1 was completed, patients tissue was sent out for methylation MGMT determination. Only patients with unmethylated MGMT promoters were eligible for the study and completed registration step 2.
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival (OS) will be measured from the start of treatment until death from any cause. At data cut off patients remaining alive will be censored at the last known date of contact.
Time Frame From start of treatment, during treatment and every 3 months following the end of treatment until death. Median follow up at time of OS data was 33 months.
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients were not evaluable - 1 patient withdrew consent and 1 patient completed less than 1 cycle of treatment
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: Months
13.2
(10.8 to 19.6)
2.Secondary Outcome
Title Progression-free Survival at 12 Months
Hide Description Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.
Time Frame At 12 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient completed one cycle)
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of patients
32
3.Secondary Outcome
Title Response Rate (RR)
Hide Description

Response Rate (RR) will be defined as the best response seen during treatment measured by CT/MRI scan every 8 weeks during treatment using McDonald Criteria.

CR=Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients off steroids.

PR=Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/decreased dose of steroids.

Stable/No Response=Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration. Stable/decreased dose of steroids.

Progressive disease = 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), worsening of evaluable disease, new lesions/site, failure to return for evaluation due to death or deteriorating condition.

Time Frame From the start of treatment, every 2 cycles (1 cycle = 28 days) during treatment until progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient complete one cycle of treatment only)
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
4
   8.7%
Partial Response
12
  26.1%
Stable/no response
28
  60.9%
Progressive Disease
0
   0.0%
No Evaluable Disease (NED)
2
   4.3%
4.Secondary Outcome
Title Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population
Hide Description

Toxicity data for combination treatment of erlotinib and bevacizumab will be collected on day 1 of every cycle (1 cycle = 28 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Time Frame From the start of treatment, at the beginning of every cycle (1 cycle = 28 days) during treatment until 30 days after completion of treatment for up to 49 cycles.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received at least one dose of study drug were evaluable for toxicity. Data for grade 3 and 4 toxicities during treatment were collected.
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: patients
Hyberbilirubinemia 1
Cerebrovascular ischemia 1
Dehydration 1
Dermatology/Skin 1
Hypertension 3
Fatigue 3
Leukocytes 1
Lymphopenia 12
Heartburn 1
Pain (not otherwise specified) 1
Pain abdomen 1
Pain head/headache 1
Bowel perforation 1
Hypophosphatemia 1
Rash/desqyamation 5
Rash/acneform 2
Syncope 1
Thrombosis/embolism 2
Wound complication 1
5.Secondary Outcome
Title Progression Free Survival at 18 Months
Hide Description Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.
Time Frame At 18 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Most patients had progressed before the 18 month time point. Data was not collected for PFS at 18 months.
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Changes in Tumor Blood Flow Based on MR Perfusion
Hide Description Data from consenting patients will be used to assess of changes in tumor blood flow based on MR perfusion using MRI scans. Two scans will be completed prior to treatment on study; the first after surgery buta before radiation, the second within 14 days before starting combination treatment or erlotinib and bevacizumab. Then scans will be completed every 2 cycles during treatment, where one cycle equals 28 days.
Time Frame Prior to study treatment (after surgery, but before radiation), just before study treatment (within 14 days prior to first treatment) and then every 2 cycles during study treatment, where 1 cycle equals 28 days for a maximum of 49 cycles.
Hide Outcome Measure Data
Hide Analysis Population Description
This was an optional portion of the study that patients could participate in. Data was not collected or analyzed for this outcome measure.
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Gene Methylation Studies (Optional)
Hide Description Tissue and plasma collected from consenting patients in the study will be used to correlate tumor tissue with imaging and outcomes. Tissue will be collected before treatment on study begins and plasma will be collected the first day of treatment (before treatment) and every odd cycle after that, whilst on study treatment. Tissue and plasma analysis will be correlated with patients imaging results and response to to treatment
Time Frame At baseline and then plasma only will be collected every odd cycle (1 cycle = 28 days) during treatment for a maximum of 49 cycles.
Hide Outcome Measure Data
Hide Analysis Population Description
This was an optional portion of the study for consenting patients. No data was collected and analyzed for this outcome measure.
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Post-Hoc Outcome
Title Progression Free Survival at 6 Months
Hide Description Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.
Time Frame At 6 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were not evaluable.
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of patients
66.3
9.Post-Hoc Outcome
Title Overall Survival at 12 Months
Hide Description Overall Survival (OS) is measured from start of treatment until death from any cause.
Time Frame At 12 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were not evaluable
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of patients
54.5
10.Post-Hoc Outcome
Title Overall Survival at 24 Months
Hide Description Overall Survival (OS) will be measured from start of treatment until death of any cause
Time Frame At 24 months from first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were not evaluable
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of patients
32.8
11.Post-Hoc Outcome
Title Median Progression Free Survival
Hide Description Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.
Time Frame From the start of treatment and every 2 cycles, where 1 cycle equals 28 days, during treatment. Median follow up at time of data was 33 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were not evaluable
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description:

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: months
9.2
(6.4 to 11.3)
Time Frame Adverse events (AE) were collected over a 9 year period for the study. AEs were assessed and recorded at the beginning of each cycle (1 cycle =28 days) while on treatment and 30 days beyond the last treatment for a maximum of 69 cycles (the most number of cycles any patient was treated on study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib and Bevacizumab Combination Treatment
Hide Arm/Group Description

Erlotinib and bevacizumab

Bevacizumab: 10mg/kg administered intravenously every 2 weeks

Erlotinib hydrochloride: 150 mg/daily orally

All-Cause Mortality
Erlotinib and Bevacizumab Combination Treatment
Affected / at Risk (%)
Total   43/48 (89.58%)    
Hide Serious Adverse Events
Erlotinib and Bevacizumab Combination Treatment
Affected / at Risk (%) # Events
Total   15/48 (31.25%)    
Cardiac disorders   
Hypertension  1  1/48 (2.08%)  1
Gastrointestinal disorders   
Nausea  1  1/48 (2.08%)  1
Vomiting  1  1/48 (2.08%)  1
Dehydration  1  1/48 (2.08%)  1
Small bowel perforation  1  1/48 (2.08%)  1
Infections and infestations   
Infection  1  1/48 (2.08%)  1
Injury, poisoning and procedural complications   
Death  1  1/48 (2.08%)  1
International Normalized Ratio of Prothrombin time (INR)  1  1/48 (2.08%)  1
Metabolism and nutrition disorders   
Creatinine  1  1/48 (2.08%)  1
Potassium - serum low  1  1/48 (2.08%)  1
Musculoskeletal and connective tissue disorders   
General Muscle Weakness  1  1/48 (2.08%)  1
Back pain  1  2/48 (4.17%)  2
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/48 (2.08%)  1
Confusion  1  1/48 (2.08%)  1
Facial droop  1  1/48 (2.08%)  1
Neuropathy - Motor  1  1/48 (2.08%)  1
Seizure  1  5/48 (10.42%)  5
Headache  1  2/48 (4.17%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  1/48 (2.08%)  1
Skin and subcutaneous tissue disorders   
Wound complication (non infectious)  1  1/48 (2.08%)  1
Vascular disorders   
Thrombosis  1  2/48 (4.17%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib and Bevacizumab Combination Treatment
Affected / at Risk (%) # Events
Total   48/48 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin (anemia)  1  10/48 (20.83%) 
Leukocytes (total white blood cells)  1  11/48 (22.92%) 
Lymphopenia  1  25/48 (52.08%) 
Platelets (thrombocytopenia)  1  10/48 (20.83%) 
Edema in limbs  1  7/48 (14.58%) 
Cardiac disorders   
Hypertension  1  12/48 (25.00%) 
Sinus bradycardia  1  3/48 (6.25%) 
Eye disorders   
Dry eye syndrome  1  6/48 (12.50%) 
Vision impairment (hemianopsia/quadrantanopia)  1  4/48 (8.33%) 
Gastrointestinal disorders   
Anorexia  1  14/48 (29.17%) 
Constipation  1  11/48 (22.92%) 
Dehydration  1  4/48 (8.33%) 
Diarrhea  1  39/48 (81.25%) 
Dry mouth  1  3/48 (6.25%) 
Flatulence  1  4/48 (8.33%) 
Heartburn  1  7/48 (14.58%) 
Hemorrhoids  1  10/48 (20.83%) 
Incontinence anal  1  3/48 (6.25%) 
Mucositis/stomatitis  1  5/48 (10.42%) 
Nausea  1  24/48 (50.00%) 
Taste alteration (dysgeusia)  1  6/48 (12.50%) 
Vomiting  1  9/48 (18.75%) 
Hemmorhage, GI rectum  1  5/48 (10.42%) 
Abdominal pain  1  11/48 (22.92%) 
General disorders   
Fatigue  1  29/48 (60.42%) 
Fever  1  3/48 (6.25%) 
Insomnia  1  4/48 (8.33%) 
Rigors  1  5/48 (10.42%) 
Weight loss  1  11/48 (22.92%) 
Immune system disorders   
Allergic rhinitis  1  6/48 (12.50%) 
Infections and infestations   
Sinus infection  1  4/48 (8.33%) 
Urinary tract infection  1  6/48 (12.50%) 
Skin rash  1  3/48 (6.25%) 
Metabolism and nutrition disorders   
Albumin - serum low  1  19/48 (39.58%) 
Alkaline phosphatase  1  3/48 (6.25%) 
Serum glutamic pyruvic transaminase (ALT/SGPT)  1  7/48 (14.58%) 
serum glutamic oxaloacetic transaminase (AST/SGOT)  1  11/48 (22.92%) 
Bicarbonate - serum low  1  3/48 (6.25%) 
Bilirubin, serum high  1  22/48 (45.83%) 
Calcium, serum low  1  8/48 (16.67%) 
Creatinine, high  1  6/48 (12.50%) 
Glucose, serum high  1  19/48 (39.58%) 
Glucose, serum low  1  8/48 (16.67%) 
Lactic acid dehydrogenase (LDH)  1  5/48 (10.42%) 
Magnesium, serum low  1  15/48 (31.25%) 
Phosphate, serum high  1  3/48 (6.25%) 
Phosphate, serum low  1  4/48 (8.33%) 
Potassium, serum high  1  8/48 (16.67%) 
Potassium, serum low  1  11/48 (22.92%) 
Proteinuria  1  6/48 (12.50%) 
Sodium, serum high  1  7/48 (14.58%) 
Decreased Uric acid  1  3/48 (6.25%) 
Chloride, serum high  1  4/48 (8.33%) 
Carbon dioxide increased  1  6/48 (12.50%) 
Protein - decreased  1  4/48 (8.33%) 
Increased Blood Urea Nitrogen (BUN)  1  6/48 (12.50%) 
Musculoskeletal and connective tissue disorders   
Extremity lower (gait/walking)  1  9/48 (18.75%) 
Joint function  1  4/48 (8.33%) 
Muscle weakness, generalized or specific area - lower extremity  1  6/48 (12.50%) 
Muscle weakness, generalized or specific area - whole body  1  7/48 (14.58%) 
Back pain  1  6/48 (12.50%) 
Extremity- limb pain  1  8/48 (16.67%) 
Joint pain  1  5/48 (10.42%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cognitive disturbance  1  4/48 (8.33%) 
Nervous system disorders   
Ataxia (incoordination)  1  3/48 (6.25%) 
Confusion  1  4/48 (8.33%) 
Dizziness  1  12/48 (25.00%) 
Memory impairment  1  12/48 (25.00%) 
Sensory Neuropathy  1  5/48 (10.42%) 
Pyramidal tract dysfunction (increased tone, hyperreflexia, positive Babinski, decreased fine motor)  1  3/48 (6.25%) 
Seizure  1  7/48 (14.58%) 
Speech impairment (e.g. dysphasia/ aphasia)  1  5/48 (10.42%) 
Tremor  1  5/48 (10.42%) 
Headache  1  23/48 (47.92%) 
Psychiatric disorders   
Mood alteration - Agitation  1  5/48 (10.42%) 
Mood alteration - Anxiety  1  5/48 (10.42%) 
Mood alteration - Depression  1  9/48 (18.75%) 
Renal and urinary disorders   
Urinary incontinence  1  4/48 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Nosebleed  1  11/48 (22.92%) 
Upper airway infection  1  3/48 (6.25%) 
Throat pain  1  3/48 (6.25%) 
Cough  1  10/48 (20.83%) 
Dyspnea (shortness of breath)  1  3/48 (6.25%) 
Voice changes/dysarthria ( hoarseness, loss or alteration in voice, laryngitis)  1  5/48 (10.42%) 
Skin and subcutaneous tissue disorders   
Brusing  1  5/48 (10.42%) 
Cheilitis  1  4/48 (8.33%) 
Dry skin  1  16/48 (33.33%) 
Nail changes  1  7/48 (14.58%) 
Pruirtus/itching  1  18/48 (37.50%) 
Rash acne  1  13/48 (27.08%) 
Rash/desquamation  1  36/48 (75.00%) 
Petechiae/purpura  1  4/48 (8.33%) 
Vascular disorders   
Thrombosis/embolism  1  3/48 (6.25%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffery Raizer, MD
Organization: Northwestern University
Phone: 312-503-4724
EMail: Jeffrey.Raizer@nm.org
Layout table for additonal information
Responsible Party: Jeffrey Raizer, Northwestern University
ClinicalTrials.gov Identifier: NCT00720356    
Other Study ID Numbers: NU 07C3
NU 07C3 ( Other Identifier: Northwestern University )
BTTC08-01 ( Other Identifier: U.T. M.D. Anderson Cancer Center )
STU00002792 ( Other Identifier: Northwestern University IRB )
First Submitted: July 19, 2008
First Posted: July 22, 2008
Results First Submitted: September 26, 2018
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018