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Trial record 7 of 141 for:    appendix cancer

Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix

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: NCT01580410
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : March 21, 2018
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma of the Appendix
Primary Peritoneal Cavity Cancer
Interventions Drug: mitomycin C
Drug: oxaliplatin
Procedure: therapeutic conventional surgery
Other: quality-of-life assessment
Drug: hyperthermic intraperitoneal chemotherapy
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin)
Hide Arm/Group Description

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Period Title: Overall Study
Started 68 68
Completed 57 60
Not Completed 11 8
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin) Total
Hide Arm/Group Description

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Total of all reporting groups
Overall Number of Baseline Participants 68 68 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  67.6%
48
  70.6%
94
  69.1%
>=65 years
22
  32.4%
20
  29.4%
42
  30.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 68 participants 136 participants
55.9  (12.9) 55.0  (14.0) 55.5  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
Female
35
  51.5%
40
  58.8%
75
  55.1%
Male
33
  48.5%
28
  41.2%
61
  44.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
Hispanic or Latino
2
   2.9%
3
   4.4%
5
   3.7%
Not Hispanic or Latino
64
  94.1%
65
  95.6%
129
  94.9%
Unknown or Not Reported
2
   2.9%
0
   0.0%
2
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.5%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   5.9%
5
   7.4%
9
   6.6%
White
63
  92.6%
62
  91.2%
125
  91.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.5%
0
   0.0%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 68 participants 136 participants
68 68 136
1.Primary Outcome
Title The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments
Hide Description If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.
Time Frame Within 4 weeks of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin)
Hide Arm/Group Description:

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Overall Number of Participants Analyzed 61 59
Measure Type: Number
Unit of Measure: number of patients with toxicities
8 5
2.Secondary Outcome
Title The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years
Hide Description [Not Specified]
Time Frame Time to first progression unless the patient’s resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin)
Hide Arm/Group Description:

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Overall Number of Participants Analyzed 57 53
Mean (Standard Error)
Unit of Measure: disease-free survival rate (%)
61.6  (8.1) 59.4  (8.1)
3.Secondary Outcome
Title The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years
Hide Description [Not Specified]
Time Frame Interval between surgery and death or date of last contact, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin)
Hide Arm/Group Description:

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Overall Number of Participants Analyzed 57 53
Mean (Standard Error)
Unit of Measure: overall survival rate (%)
75.7  (6.4) 79.3  (5.7)
4.Secondary Outcome
Title Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)
Hide Description The FACT-G (Functional Assessment of Cancer Therapy – General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-“not at all”, 1- “a little bit”, 2-“somewhat”, 3- “quite a bit” and 4-“very much”. The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.
Time Frame Throughout study completion, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin)
Hide Arm/Group Description:

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Overall Number of Participants Analyzed 57 53
Mean (Standard Error)
Unit of Measure: units on a scale
85.5  (1.6) 89.6  (1.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Mitomycin C) Arm II (Oxaliplatin)
Hide Arm/Group Description

Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.

mitomycin C: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

oxaliplatin: Given by HIPEC

therapeutic conventional surgery: Undergo surgery

quality-of-life assessment: Ancillary studies

hyperthermic intraperitoneal chemotherapy: Undergo HIPEC

All-Cause Mortality
Arm I (Mitomycin C) Arm II (Oxaliplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/58 (1.72%)      1/61 (1.64%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Mitomycin C) Arm II (Oxaliplatin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/58 (87.93%)      54/61 (88.52%)    
Cardiac disorders     
Hypotension  1  2/58 (3.45%)  2 3/61 (4.92%)  3
Atrial fibrillation  1  2/58 (3.45%)  2 2/61 (3.28%)  2
Sinus tachycardia  1  1/58 (1.72%)  1 2/61 (3.28%)  2
Gastrointestinal disorders     
Nausea  1  7/58 (12.07%)  7 10/61 (16.39%)  10
Diarrhea  1  3/58 (5.17%)  3 9/61 (14.75%)  9
Obstruction, GI: Small bowel  1  1/58 (1.72%)  1 1/61 (1.64%)  1
functional obstruction of bowel  1  8/58 (13.79%)  8 10/61 (16.39%)  10
Malabsorption  1  2/58 (3.45%)  2 4/61 (6.56%)  4
Fistula, GI: Abdomen  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Leak (including anastomotic), GI: Leak  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Leak (including anastomotic), GI: Small bowel  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Necrosis, GI: Small bowel  1  1/58 (1.72%)  1 0/61 (0.00%)  0
General disorders     
Anorexia  1  10/58 (17.24%)  10 8/61 (13.11%)  8
Fatigue  1  6/58 (10.34%)  6 7/61 (11.48%)  7
Weight loss  1  4/58 (6.90%)  4 2/61 (3.28%)  2
Dehydration  1  1/58 (1.72%)  1 5/61 (8.20%)  5
Confusion  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Mood alteration: Agitation  1  4/58 (6.90%)  4 2/61 (3.28%)  2
Anxiety  1  1/58 (1.72%)  1 2/61 (3.28%)  2
Depression  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Pain: Abdomen  1  5/58 (8.62%)  5 4/61 (6.56%)  4
Pain: Chest/thorax  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Death not associated with CTCAE term: Multi-organ failure  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Pain: Muscle  1  2/58 (3.45%)  2 3/61 (4.92%)  3
Pain: Scrotum  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Mental status  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Infections and infestations     
Infection Bladder  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Cystitis  1  1/58 (1.72%)  1 0/61 (0.00%)  0
infection associated with Lymphopenia  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Lung infection  1  9/58 (15.52%)  9 10/61 (16.39%)  11
Urinary with low grade neutropenia  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen  1  3/58 (5.17%)  3 1/61 (1.64%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils: Peritoneal cavity  1  2/58 (3.45%)  2 2/61 (3.28%)  2
Lung Infection with high grade neutropenia  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Infection with unknown ANC: Peritoneal cavity  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Infection with high grade neutropenia  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Blood Infection with high grade neutropenia  1  3/58 (5.17%)  3 1/61 (1.64%)  1
Investigations     
Low WBC  1  3/58 (5.17%)  3 2/61 (3.28%)  2
low Platelets  1  1/58 (1.72%)  1 3/61 (4.92%)  4
Low Hemoglobin  1  35/58 (60.34%)  35 36/61 (59.02%)  36
Creatinine  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Low ANC  1  1/58 (1.72%)  1 4/61 (6.56%)  4
hyperglycemia  1  3/58 (5.17%)  3 6/61 (9.84%)  6
hypocalcemia  1  1/58 (1.72%)  1 0/61 (0.00%)  0
hyponatremia  1  3/58 (5.17%)  3 2/61 (3.28%)  2
hypokalemia  1  7/58 (12.07%)  7 1/61 (1.64%)  1
hypoalbuminemia  1  16/58 (27.59%)  16 19/61 (31.15%)  19
hyperbilirubinemia  1  1/58 (1.72%)  1 0/61 (0.00%)  0
serum glutamic pyruvic transaminase  1  12/58 (20.69%)  12 9/61 (14.75%)  9
hypophosphatemia  1  13/58 (22.41%)  13 14/61 (22.95%)  14
serum glutamic oxaloacetic transaminase  1  16/58 (27.59%)  16 7/61 (11.48%)  7
Acidosis  1  2/58 (3.45%)  2 4/61 (6.56%)  4
creatine phosphokinase  1  1/58 (1.72%)  1 0/61 (0.00%)  0
disseminated intravascular coagulation  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Prolonged QTc interval  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Lymphopenia  1  20/58 (34.48%)  21 25/61 (40.98%)  28
International Normalized Ratio of prothrombin time  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Cardiac troponin I  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  2/58 (3.45%)  2 3/61 (4.92%)  3
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  11/58 (18.97%)  11 14/61 (22.95%)  14
Pneumonitis/pulmonary infiltrates  1  1/58 (1.72%)  1 5/61 (8.20%)  5
Pleural effusion (non-malignant)  1  7/58 (12.07%)  7 8/61 (13.11%)  8
Cough  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Pneumothorax  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Prolonged intubation after pulmonary resection (>24 hrs after surgery)  1  2/58 (3.45%)  2 3/61 (4.92%)  3
Skin and subcutaneous tissue disorders     
Pain: Skin  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Ulceration  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Vascular disorders     
Hemorrhage, GI: Lower GI  1  2/58 (3.45%)  2 1/61 (1.64%)  1
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative  1  2/58 (3.45%)  2 0/61 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0
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%
Arm I (Mitomycin C) Arm II (Oxaliplatin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/58 (100.00%)      61/61 (100.00%)    
Blood and lymphatic system disorders     
Hematoma  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Cardiac disorders     
Hypotension  1  8/58 (13.79%)  8 4/61 (6.56%)  4
Neuropathy: sensory  1  6/58 (10.34%)  7 1/61 (1.64%)  1
Cardiac Arrhythmia - Other  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Conduction abnormality/atrioventricular heart block  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Right ventricular dysfunction  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Supraventricular and nodal arrhythmia: Sinus bradycardia  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Sinus tachycardia  1  9/58 (15.52%)  9 5/61 (8.20%)  5
Supraventricular and nodal arrhythmia: Supraventricular tachycardia  1  1/58 (1.72%)  1 3/61 (4.92%)  3
Eye disorders     
Watery eye (epiphora, tearing)  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  19/58 (32.76%)  19 18/61 (29.51%)  18
Vomiting  1  24/58 (41.38%)  24 17/61 (27.87%)  17
Diarrhea  1  18/58 (31.03%)  18 8/61 (13.11%)  8
Constipation  1  6/58 (10.34%)  6 4/61 (6.56%)  4
Ascites (non-malignant)  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Flatulence  1  2/58 (3.45%)  2 1/61 (1.64%)  1
functional obstruction of bowel  1  5/58 (8.62%)  5 4/61 (6.56%)  4
Leak (including anastomotic), GI: Pancreas  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Leak (including anastomotic), GI: Leak  1  1/58 (1.72%)  1 0/61 (0.00%)  0
General disorders     
Anorexia  1  20/58 (34.48%)  20 19/61 (31.15%)  19
Hypertension  1  2/58 (3.45%)  2 3/61 (4.92%)  3
Taste alteration  1  4/58 (6.90%)  4 4/61 (6.56%)  4
Insomnia  1  11/58 (18.97%)  11 5/61 (8.20%)  5
Rigors/chills  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Sweating  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Fatigue  1  30/58 (51.72%)  30 22/61 (36.07%)  22
Weight loss  1  26/58 (44.83%)  26 34/61 (55.74%)  34
Dysphagia  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Fever without neutropenia  1  6/58 (10.34%)  6 5/61 (8.20%)  5
Constitutional Symptoms - Other  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Edema: trunk/genital  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Dehydration  1  2/58 (3.45%)  2 2/61 (3.28%)  2
Confusion  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Mood alteration: Agitation  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Anxiety  1  5/58 (8.62%)  5 4/61 (6.56%)  4
Depression  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Distension bloating, abdominal  1  4/58 (6.90%)  4 1/61 (1.64%)  1
Pain: Abdomen  1  8/58 (13.79%)  8 18/61 (29.51%)  18
Pain: Joint  1  2/58 (3.45%)  2 1/61 (1.64%)  1
Pain: Back  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Pain Bladder  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Wound complication, non-infectious  1  10/58 (17.24%)  10 8/61 (13.11%)  8
Hiccoughs (hiccups, singultus)  1  2/58 (3.45%)  2 1/61 (1.64%)  1
Pain: Muscle  1  4/58 (6.90%)  4 5/61 (8.20%)  5
Pain: Neuralgia/peripheral nerve  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Pain Oral cavity  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Pain: Stomach  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Pain: Urethra  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Cognitive disturbance  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Intra-operative injury: NERVES: Peripheral sensory  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Infections and infestations     
Infection Bladder  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Lung infection  1  2/58 (3.45%)  2 0/61 (0.00%)  0
Urinary with low grade neutropenia  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Mucositis/stomatitis Oral cavity  1  1/58 (1.72%)  1 2/61 (3.28%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound  1  2/58 (3.45%)  2 1/61 (1.64%)  1
Investigations     
Low WBC  1  11/58 (18.97%)  11 22/61 (36.07%)  22
low Platelets  1  33/58 (56.90%)  33 27/61 (44.26%)  27
Low Hemoglobin  1  22/58 (37.93%)  22 22/61 (36.07%)  22
Alkaline phosphatase  1  31/58 (53.45%)  31 27/61 (44.26%)  27
Creatinine  1  2/58 (3.45%)  2 2/61 (3.28%)  2
Proteinuria  1  2/58 (3.45%)  2 1/61 (1.64%)  1
Low ANC  1  2/58 (3.45%)  2 3/61 (4.92%)  3
hyperglycemia  1  42/58 (72.41%)  42 42/61 (68.85%)  42
hypocalcemia  1  3/58 (5.17%)  3 4/61 (6.56%)  4
hypomagnesemia  1  8/58 (13.79%)  8 6/61 (9.84%)  6
hyponatremia  1  35/58 (60.34%)  35 29/61 (47.54%)  29
hypokalemia  1  26/58 (44.83%)  26 31/61 (50.82%)  31
Bicarbonate serum-low  1  2/58 (3.45%)  2 0/61 (0.00%)  0
hypoalbuminemia  1  33/58 (56.90%)  33 35/61 (57.38%)  35
hyperbilirubinemia  1  2/58 (3.45%)  2 4/61 (6.56%)  4
serum glutamic pyruvic transaminase  1  31/58 (53.45%)  31 37/61 (60.66%)  37
hypophosphatemia  1  5/58 (8.62%)  5 6/61 (9.84%)  6
serum glutamic oxaloacetic transaminase  1  31/58 (53.45%)  31 43/61 (70.49%)  43
hypermagnesemia  1  2/58 (3.45%)  2 1/61 (1.64%)  1
hyperkalemia  1  2/58 (3.45%)  2 4/61 (6.56%)  4
hypernatremia  1  2/58 (3.45%)  2 1/61 (1.64%)  1
hypertriglyceridemia  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Lymphopenia  1  24/58 (41.38%)  24 21/61 (34.43%)  21
International Normalized Ratio of prothrombin time  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  6/58 (10.34%)  6 3/61 (4.92%)  3
Pleural effusion (non-malignant)  1  19/58 (32.76%)  19 10/61 (16.39%)  10
Cough  1  6/58 (10.34%)  6 2/61 (3.28%)  2
Atelectasis  1  20/58 (34.48%)  20 16/61 (26.23%)  16
Pneumothorax  1  3/58 (5.17%)  3 5/61 (8.20%)  5
Infection with unknown ANC Lung (pneumonia)  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Prolonged chest tube drainage or air leak after pulmonary resection  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatology/Skin  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Rash/desquamation  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Rash: acne/acneiform  1  1/58 (1.72%)  1 1/61 (1.64%)  1
Skin breakdown/decubitus ulcer  1  1/58 (1.72%)  1 2/61 (3.28%)  2
Vascular disorders     
Thrombosis/thrombus/embolism  1  2/58 (3.45%)  2 1/61 (1.64%)  1
Phlebitis  1  1/58 (1.72%)  1 0/61 (0.00%)  0
Edema: limb  1  2/58 (3.45%)  2 3/61 (4.92%)  3
Edema: viscera  1  3/58 (5.17%)  3 1/61 (1.64%)  1
Hemorrhage GU: Urinary  1  3/58 (5.17%)  3 2/61 (3.28%)  2
Thrombosis/embolism (vascular access-related)  1  1/58 (1.72%)  1 0/61 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0
Indicates events were collected by systematic assessment
The worst adverse event of each type was recorded for the course of treatment.
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: Dr. Edward Levine
Organization: Wake Forest University Health Sciences
Phone: 336-716-2763
EMail: elevine@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01580410     History of Changes
Obsolete Identifiers: NCT00904267
Other Study ID Numbers: IRB00009326
NCI-2009-00947 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 59109 ( Other Identifier: Wake Forest University Health Sciences )
First Submitted: April 17, 2012
First Posted: April 19, 2012
Results First Submitted: December 21, 2017
Results First Posted: March 21, 2018
Last Update Posted: July 3, 2018