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A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS)

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ClinicalTrials.gov Identifier: NCT00876915
Recruitment Status : Terminated (slow enrollment and lack of continuing funds)
First Posted : April 7, 2009
Results First Posted : October 12, 2015
Last Update Posted : November 24, 2015
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eisai Inc.
Information provided by (Responsible Party):
Charles Francis, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Venous Thromboembolism
Pulmonary Embolism
Intervention Drug: dalteparin injection
Enrollment 218
Recruitment Details Participants screened for the study but deemed low or medium risk by Khorona scoring will be offered to consent to a one time baseline blood sample. These samples will be used as the control group to establish the value of TF as a predictive marker for VTE in ambulatory cancer patients as described in the Secondary Objectives.
Pre-assignment Details Participants who undergo a baseline US/CT scan and are found to have a DVT/PE will be considered a screen failure and will not be randomized and continue on in the study. In addition, if any of the screening criteria are not met, these subjects will be considered screen failures.
Arm/Group Title High Risk Dalteparin Injection High Risk No Therapy Low or Medium Risk Group
Hide Arm/Group Description

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care) Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
Period Title: Overall Study
Started 50 48 101
Week 4 38 45 0
Week 8 33 36 0
Completed 31 34 101
Not Completed 19 14 0
Arm/Group Title High Risk Randomized to Dalteparin Injection High Risk Randomized to No Therapy Low Risk Total
Hide Arm/Group Description

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care) Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2 Total of all reporting groups
Overall Number of Baseline Participants 50 48 101 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 101 participants 199 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  68.0%
35
  72.9%
74
  73.3%
143
  71.9%
>=65 years
16
  32.0%
13
  27.1%
27
  26.7%
56
  28.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 101 participants 199 participants
60  (10) 58  (12) 58  (13) 58  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 101 participants 199 participants
Female
21
  42.0%
24
  50.0%
41
  40.6%
86
  43.2%
Male
29
  58.0%
24
  50.0%
60
  59.4%
113
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 101 participants 199 participants
Hispanic or Latino
2
   4.0%
3
   6.3%
1
   1.0%
6
   3.0%
Not Hispanic or Latino
48
  96.0%
45
  93.8%
96
  95.0%
189
  95.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
4
   4.0%
4
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 101 participants 199 participants
American Indian or Alaska Native
2
   4.0%
2
   4.2%
0
   0.0%
4
   2.0%
Asian
2
   4.0%
0
   0.0%
1
   1.0%
3
   1.5%
Native Hawaiian or Other Pacific Islander
1
   2.0%
1
   2.1%
0
   0.0%
2
   1.0%
Black or African American
7
  14.0%
8
  16.7%
9
   8.9%
24
  12.1%
White
38
  76.0%
37
  77.1%
91
  90.1%
166
  83.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 101 participants 199 participants
Canada 4 3 0 7
United States 46 45 101 192
1.Primary Outcome
Title Percentage of Patients With Venous Thromboembolisms
Hide Description The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dalteparin Injection No Therapy
Hide Arm/Group Description:

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Overall Number of Participants Analyzed 50 48
Measure Type: Number
Unit of Measure: percentage of participants
12 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dalteparin Injection, No Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4795
Comments [Not Specified]
Method stratified Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.695
Confidence Interval (2-Sided) 95%
0.235 to 1.890
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Patients Who Experienced Clinically Significant Bleeding Events.
Hide Description The percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma > 25 cm², epistaxis > 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding > 5 mins, hemoptysis, hematemesis or prolonged bleeding (> 5 minutes) after venipuncture.
Time Frame 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dalteparin Injection No Therapy
Hide Arm/Group Description:

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Overall Number of Participants Analyzed 50 48
Measure Type: Number
Unit of Measure: percentage of participants
14 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dalteparin Injection, No Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0252
Comments [Not Specified]
Method stratified Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 7.019
Confidence Interval (2-Sided) 95%
1.236 to 131.632
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
Hide Description Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients.
Time Frame baseline value of tissue factor
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Arm/Group Title High Risk Low Risk
Hide Arm/Group Description:
High Risk participants ambulatory cancer patients with Khorona scores 3+
Low Risk ambulatory cancer patients with Khorona scores of 0-2
Overall Number of Participants Analyzed 89 101
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.669  (1.35) 0.187  (0.492)
4.Secondary Outcome
Title The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
Hide Description Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Time Frame baseline value of D-Dimer
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Arm/Group Title High Risk Low Risk
Hide Arm/Group Description:
High Risk participants ambulatory cancer patients with Khorona scores 3+
Low Risk ambulatory cancer patients with Khorona scores of 0-2
Overall Number of Participants Analyzed 89 101
Mean (Standard Deviation)
Unit of Measure: ug/mL
2.99  (5.67) 1.87  (3.67)
5.Secondary Outcome
Title The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
Hide Description Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Time Frame baseline value of Human F12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Arm/Group Title High Risk Low Risk
Hide Arm/Group Description:
High Risk participants ambulatory cancer patients with Khorona scores 3+
Low Risk ambulatory cancer patients with Khorona scores of 0-2
Overall Number of Participants Analyzed 89 101
Mean (Standard Deviation)
Unit of Measure: ng/mL
484.7  (1167.6) 306.3  (552.7)
6.Secondary Outcome
Title The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
Hide Description Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Time Frame baseline value of TFPI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Arm/Group Title High Risk Low Risk
Hide Arm/Group Description:
High Risk participants ambulatory cancer patients with Khorona scores 3+
Low Risk ambulatory cancer patients with Khorona scores of 0-2
Overall Number of Participants Analyzed 89 101
Mean (Standard Deviation)
Unit of Measure: pg/mL
813.6  (391.3) 738.2  (351.1)
7.Secondary Outcome
Title The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
Hide Description Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Time Frame baseline value of FVIIa
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Arm/Group Title High Risk Low Risk
Hide Arm/Group Description:
High Risk participants ambulatory cancer patients with Khorona scores 3+
Low Risk ambulatory cancer patients with Khorona scores of 0-2
Overall Number of Participants Analyzed 89 101
Mean (Standard Deviation)
Unit of Measure: pM
151.2  (59.4) 148.6  (92.2)
8.Secondary Outcome
Title The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
Hide Description Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Time Frame baseline value of TAT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Arm/Group Title High Risk Low Risk
Hide Arm/Group Description:
High Risk participants ambulatory cancer patients with Khorona scores 3+
Low Risk ambulatory cancer patients with Khorona scores of 0-2
Overall Number of Participants Analyzed 89 101
Mean (Standard Deviation)
Unit of Measure: ug/L
9.89  (20.09) 12.44  (21.42)
Time Frame 13 weeks, 12 weeks on active treatment + 1 additional week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalteparin Injection No Therapy
Hide Arm/Group Description

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
All-Cause Mortality
Dalteparin Injection No Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dalteparin Injection No Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/50 (52.00%)      18/48 (37.50%)    
Blood and lymphatic system disorders     
Hemoglobin  1  1/50 (2.00%)  1 1/48 (2.08%)  3
Platelets  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Cardiac disorders     
Cardiac Troponin T  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Hypotension  1  4/50 (8.00%)  4 2/48 (4.17%)  2
Ventricular arrhythmia - ventricular tachycardia  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Gastrointestinal disorders     
ascites  1  1/50 (2.00%)  1 1/48 (2.08%)  1
anorexia  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Colitis  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Cholangitis-bilary tree stricture  1  0/50 (0.00%)  0 2/48 (4.17%)  2
Constipation  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Dehydration  1  4/50 (8.00%)  5 3/48 (6.25%)  4
Diarrhea  1  1/50 (2.00%)  2 1/48 (2.08%)  2
Dysphagia  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Esophagitis  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Hemorrhage, GI - Rectum  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Hemorrhage, GI - Upper GI NOS  1  0/50 (0.00%)  0 2/48 (4.17%)  6
Mucositis (functional/symptomatic) - oral cavity  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Nausea  1  3/50 (6.00%)  5 2/48 (4.17%)  2
Pain - Abdomen NOS  1  4/50 (8.00%)  5 3/48 (6.25%)  5
Pain - Anus  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Pain - Esophagus  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Perforation, GI  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Ulcer, GI - Duodenum  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Vomiting  1  3/50 (6.00%)  5 3/48 (6.25%)  3
General disorders     
fatigue  1  3/50 (6.00%)  3 1/48 (2.08%)  1
Fever  1  1/50 (2.00%)  1 3/48 (6.25%)  3
Pain - NOS  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Rigors/chills  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Obstruction - biliary tree  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Liver Dysfunction  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Infections and infestations     
febrile neutropenia  1  3/50 (6.00%)  3 1/48 (2.08%)  1
Infection - Other (Sepsis)  1  2/50 (4.00%)  2 3/48 (6.25%)  3
Infection - Lung (pneumonia)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Infection - Other (Spontaneous Bacterial Peritonitis)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Infection - Other  1  2/50 (4.00%)  2 0/48 (0.00%)  0
Infection - Other (skin cellulitis)  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Infection with normal ANC  1  3/50 (6.00%)  3 2/48 (4.17%)  2
Pneumonitis  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Investigations     
Death  1  2/50 (4.00%)  2 1/48 (2.08%)  1
Metabolism and nutrition disorders     
Acidosis  1  0/50 (0.00%)  0 1/48 (2.08%)  1
alkaline phosphatase  1  0/50 (0.00%)  0 1/48 (2.08%)  1
ALT, SGPT (serum glutamic pyruvic)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
bilirubin (hyperbilirubinemia)  1  0/50 (0.00%)  0 2/48 (4.17%)  2
Creatinine  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Glucose, serum - high (hyperglycemia)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Glucose, serum - low (hypoglycemia)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Potassium, serum - high (hyperkalemia)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
sodium, serum - low (hyponatremia)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
weight loss  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Musculoskeletal and connective tissue disorders     
Fracture  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Muscle weakness - whole body/generalized  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Pain - Joint  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Nervous system disorders     
Encephalopathy  1  2/50 (4.00%)  2 0/48 (0.00%)  0
Extrapyramidal/involuntary movement/restlessness  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Memory Impairment  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Neurology - Other (loss of consciousness)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Neurology - Other (pseudoseizures)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Neuropathy - motor  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Pain - head/headache  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Psychiatric disorders     
Neurology - Other (altered mental status)  1  0/50 (0.00%)  0 2/48 (4.17%)  2
Somnolence/depressed level of consciousness  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Reproductive system and breast disorders     
Hemorrhage, GU - Vagina  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
aspiration  1  0/50 (0.00%)  0 1/48 (2.08%)  1
cough  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Dyspnea  1  3/50 (6.00%)  3 0/48 (0.00%)  0
Hypoxia  1  3/50 (6.00%)  3 2/48 (4.17%)  2
Pain - chest/thorax NOS  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Social circumstances     
Confusion  1  1/50 (2.00%)  2 0/48 (0.00%)  0
Vascular disorders     
Thrombosis/Thrombus/embolism  1  3/50 (6.00%)  3 1/48 (2.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dalteparin Injection No Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/50 (78.00%)      43/48 (89.58%)    
Blood and lymphatic system disorders     
Anemia  1  0/50 (0.00%)  0 1/48 (2.08%)  1
blood - other (leukocytosis)  1  1/50 (2.00%)  1 2/48 (4.17%)  2
edema: limb  1  4/50 (8.00%)  6 2/48 (4.17%)  2
edema: head and neck  1  0/50 (0.00%)  0 1/48 (2.08%)  1
edema  1  0/50 (0.00%)  0 1/48 (2.08%)  1
hemoglobin  1  17/50 (34.00%)  21 20/48 (41.67%)  21
hemorrhage, pulmonary/upper respiratory - nose  1  3/50 (6.00%)  3 1/48 (2.08%)  1
leukocytes (total WBC)  1  13/50 (26.00%)  13 14/48 (29.17%)  17
lymphopenia  1  3/50 (6.00%)  3 1/48 (2.08%)  1
lymphatics - other (anasarca)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
neutrophils/granulocytes (ANC/AGC)  1  10/50 (20.00%)  10 10/48 (20.83%)  11
platelets  1  7/50 (14.00%)  7 10/48 (20.83%)  11
Cardiac disorders     
hypertension  1  1/50 (2.00%)  1 1/48 (2.08%)  1
hypotension  1  5/50 (10.00%)  6 1/48 (2.08%)  1
pain - cardiac/chest  1  0/50 (0.00%)  0 1/48 (2.08%)  1
supraventricular arrythmia - sinus tachycardia  1  3/50 (6.00%)  3 4/48 (8.33%)  4
supraventricular arrythmia - atrial fibrillation  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Ear and labyrinth disorders     
pain - other (ear)  1  1/50 (2.00%)  1 1/48 (2.08%)  1
tinnitus  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Endocrine disorders     
syndromes - other (serotonergic syndrome)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Gastrointestinal disorders     
Ascites  1  0/50 (0.00%)  0 1/48 (2.08%)  1
constipation  1  13/50 (26.00%)  13 7/48 (14.58%)  8
distension/bloating, abdominal  1  0/50 (0.00%)  0 1/48 (2.08%)  1
dysphagia  1  4/50 (8.00%)  4 1/48 (2.08%)  1
dry mouth  1  0/50 (0.00%)  0 1/48 (2.08%)  1
esophagitis  1  1/50 (2.00%)  1 1/48 (2.08%)  1
gastrointestinal - incontinence, bowel  1  1/50 (2.00%)  1 0/48 (0.00%)  0
GI - other  1  0/50 (0.00%)  0 1/48 (2.08%)  1
GI - other (biliary tree obstruction)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
gastrointestinal - other (gas pain)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
heartburn/dyspepsia  1  3/50 (6.00%)  3 0/48 (0.00%)  0
henorrhage, GI - Rectum  1  1/50 (2.00%)  1 0/48 (0.00%)  0
hemorrhage, GI-Lower GI NOS  1  1/50 (2.00%)  2 0/48 (0.00%)  0
hemorrhage, GI-upper GI NOS  1  1/50 (2.00%)  2 0/48 (0.00%)  0
nausea  1  20/50 (40.00%)  22 23/48 (47.92%)  25
obstruction - Gtube  1  0/50 (0.00%)  0 1/48 (2.08%)  1
vomiting  1  7/50 (14.00%)  8 15/48 (31.25%)  17
pain - stomach  1  0/50 (0.00%)  0 1/48 (2.08%)  1
salivary gland changes/saliva  1  1/50 (2.00%)  1 1/48 (2.08%)  1
mucositis (fuctional/symptomatic) - oral cavity  1  2/50 (4.00%)  2 4/48 (8.33%)  4
taste alteration (dysgeusia)  1  1/50 (2.00%)  1 3/48 (6.25%)  3
ulcer, GI - stomach  1  1/50 (2.00%)  1 0/48 (0.00%)  0
General disorders     
allergic reaction/hypersensetivity  1  3/50 (6.00%)  3 0/48 (0.00%)  0
constitutional symptoms - other (cachexia)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
fatigue  1  18/50 (36.00%)  18 21/48 (43.75%)  24
insomnia  1  4/50 (8.00%)  4 4/48 (8.33%)  4
pain - abdomen NOS  1  8/50 (16.00%)  9 7/48 (14.58%)  7
weight loss  1  11/50 (22.00%)  11 10/48 (20.83%)  10
pain - chest/thorax NOS  1  1/50 (2.00%)  1 0/48 (0.00%)  0
pain - back  1  0/50 (0.00%)  0 1/48 (2.08%)  1
pain - extremity - limb  1  3/50 (6.00%)  3 2/48 (4.17%)  3
pain - head/headache  1  3/50 (6.00%)  3 2/48 (4.17%)  2
pain - other (groin)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
pain - other (jaw)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
pain - NOS  1  1/50 (2.00%)  1 0/48 (0.00%)  0
pain - other (peg tube site)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
rigors/chills  1  3/50 (6.00%)  3 4/48 (8.33%)  5
Hepatobiliary disorders     
liver dysfunction  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Infections and infestations     
febrile neutropenia  1  1/50 (2.00%)  1 0/48 (0.00%)  0
fever  1  11/50 (22.00%)  12 3/48 (6.25%)  3
flu-like symptoms  1  3/50 (6.00%)  3 1/48 (2.08%)  1
infection - conjunctiva  1  0/50 (0.00%)  0 1/48 (2.08%)  1
infection - other (sinus)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
infection - other  1  0/50 (0.00%)  0 1/48 (2.08%)  1
infection - other (skin, cellulitis)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
infection - other (thrush)  1  2/50 (4.00%)  3 2/48 (4.17%)  2
infection - other (urinary tract NOS)  1  1/50 (2.00%)  1 1/48 (2.08%)  1
infection - other (upper respiratory)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
infection with grade 2 neutrophils - skin (cellulitis)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
infection with normal ANC  1  2/50 (4.00%)  2 0/48 (0.00%)  0
infection with normal ANC - bronchus  1  1/50 (2.00%)  1 0/48 (0.00%)  0
infection with unknown ANC  1  1/50 (2.00%)  1 0/48 (0.00%)  0
syndromes - other (systemic inflammatory response syndrome (SIRS))  1  1/50 (2.00%)  1 0/48 (0.00%)  0
Injury, poisoning and procedural complications     
bruising  1  5/50 (10.00%)  6 0/48 (0.00%)  0
Metabolism and nutrition disorders     
Albumin, serum - low (hypoalbuminemia)  1  7/50 (14.00%)  7 8/48 (16.67%)  8
Alkaline Phosphatase  1  3/50 (6.00%)  3 8/48 (16.67%)  9
ALT  1  13/50 (26.00%)  13 10/48 (20.83%)  11
Anorexia  1  9/50 (18.00%)  9 12/48 (25.00%)  12
AST  1  9/50 (18.00%)  9 13/48 (27.08%)  16
bilirubin (hyperbilirubinemia)  1  3/50 (6.00%)  3 1/48 (2.08%)  1
calcium, serum - high (hypercalcemia)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
calcium, serum - low (hypocalcemia)  1  8/50 (16.00%)  8 8/48 (16.67%)  8
colitis  1  1/50 (2.00%)  1 0/48 (0.00%)  0
creatinine  1  3/50 (6.00%)  3 3/48 (6.25%)  3
dehydration  1  4/50 (8.00%)  5 3/48 (6.25%)  3
diarrhea  1  9/50 (18.00%)  12 13/48 (27.08%)  15
glucose, serum - high (hyperglycemia)  1  11/50 (22.00%)  11 10/48 (20.83%)  11
glucose, serum - low (hypoglycemia)  1  0/50 (0.00%)  0 2/48 (4.17%)  3
magnesium, serum - low (hypomagnesemia)  1  1/50 (2.00%)  1 2/48 (4.17%)  2
potassium, serum-high (hyperkalemia)  1  5/50 (10.00%)  6 2/48 (4.17%)  4
potassium, serum-low (hypokalemia)  1  3/50 (6.00%)  3 6/48 (12.50%)  7
sodium, serum-high (hypernatremia)  1  1/50 (2.00%)  1 1/48 (2.08%)  1
sodium, serum-low (hyponatremia)  1  5/50 (10.00%)  6 1/48 (2.08%)  1
metabolic/laboratory - other (azotemia)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Musculoskeletal and connective tissue disorders     
pain - muscle  1  1/50 (2.00%)  1 1/48 (2.08%)  1
pain - joint  1  2/50 (4.00%)  2 0/48 (0.00%)  0
pain - other (knee)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
muscle weakness - whole body/generalized  1  1/50 (2.00%)  1 0/48 (0.00%)  0
tremor  1  2/50 (4.00%)  2 0/48 (0.00%)  0
Nervous system disorders     
dizziness  1  3/50 (6.00%)  3 8/48 (16.67%)  8
neuropathy - sensory  1  2/50 (4.00%)  2 15/48 (31.25%)  15
neurology - other (neuropraxia)  1  1/50 (2.00%)  1 0/48 (0.00%)  0
syncope  1  1/50 (2.00%)  1 2/48 (4.17%)  2
Psychiatric disorders     
confusion  1  3/50 (6.00%)  5 2/48 (4.17%)  2
memory impairment  1  0/50 (0.00%)  0 1/48 (2.08%)  1
psychosis (hallucinations/delusions)  1  3/50 (6.00%)  3 1/48 (2.08%)  1
mood alteration - agitation  1  3/50 (6.00%)  3 0/48 (0.00%)  0
mood alteration - anxiety  1  1/50 (2.00%)  1 1/48 (2.08%)  1
mood alteration - depression  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Renal and urinary disorders     
incontinence, urinary  1  1/50 (2.00%)  1 0/48 (0.00%)  0
pain - dysuria (painful urination)  1  2/50 (4.00%)  2 0/48 (0.00%)  0
urinary frequency/urgency  1  2/50 (4.00%)  2 2/48 (4.17%)  2
urinary retention  1  1/50 (2.00%)  1 1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders     
bronchospasm  1  0/50 (0.00%)  0 2/48 (4.17%)  2
cough  1  5/50 (10.00%)  5 4/48 (8.33%)  4
dyspnea (shortness of breath)  1  4/50 (8.00%)  4 4/48 (8.33%)  4
hiccoughs  1  1/50 (2.00%)  1 2/48 (4.17%)  2
hypoxia  1  1/50 (2.00%)  1 0/48 (0.00%)  0
pain - throat  1  5/50 (10.00%)  5 1/48 (2.08%)  1
pneumothorax  1  1/50 (2.00%)  1 0/48 (0.00%)  0
rhinitis  1  1/50 (2.00%)  1 1/48 (2.08%)  1
voice changes  1  2/50 (4.00%)  2 0/48 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  0/50 (0.00%)  0 1/48 (2.08%)  1
flushing  1  1/50 (2.00%)  1 0/48 (0.00%)  0
hyperpigmentation  1  1/50 (2.00%)  1 1/48 (2.08%)  1
pain - skin  1  0/50 (0.00%)  0 1/48 (2.08%)  1
pruritus/itching  1  0/50 (0.00%)  0 2/48 (4.17%)  3
rash/desquamation  1  3/50 (6.00%)  3 1/48 (2.08%)  1
rash: hand-foot skin reaction  1  3/50 (6.00%)  3 4/48 (8.33%)  4
rash: acne/acneiform  1  0/50 (0.00%)  0 1/48 (2.08%)  1
skin breakdown (thighs)  1  0/50 (0.00%)  0 1/48 (2.08%)  1
skin breakdown/decubitus ulcer  1  0/50 (0.00%)  0 1/48 (2.08%)  1
sweating (diaphoresis)  1  2/50 (4.00%)  2 2/48 (4.17%)  2
dermatitis - chemoradiation  1  0/50 (0.00%)  0 1/48 (2.08%)  1
ulceration  1  0/50 (0.00%)  0 1/48 (2.08%)  1
Vascular disorders     
phlebitis  1  1/50 (2.00%)  1 0/48 (0.00%)  0
thrombosis/thrombus/embolism  1  0/50 (0.00%)  0 6/48 (12.50%)  6
vascular - thrombosis  1  1/50 (2.00%)  1 2/48 (4.17%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Charles Francis, MD
Organization: University of Rochester
Phone: (585) 275-5823
Responsible Party: Charles Francis, University of Rochester
ClinicalTrials.gov Identifier: NCT00876915     History of Changes
Other Study ID Numbers: 25387
1R01HL095109-01 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2009
First Posted: April 7, 2009
Results First Submitted: July 24, 2015
Results First Posted: October 12, 2015
Last Update Posted: November 24, 2015