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PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00088413
Recruitment Status : Completed
First Posted : July 26, 2004
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
James Gulley, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma
Colorectal Cancer
Ovarian Cancer
Breast Cancer
Interventions Biological: PANVAC-V
Biological: PANVAC-F
Drug: Sargramostim (GM-CSF, Leukine)
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colorectal Cancer Cohort Non-Colorectal Cancer Cohort Breast Cohort Ovarian Cohort
Hide Arm/Group Description Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy. Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy. Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy. Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Period Title: Overall Study
Started 10 15 12 14
Completed 0 0 0 0
Not Completed 10 15 12 14
Reason Not Completed
Limited supply of trmt drug (PANVAC-f)             0             0             1             0
Adverse Events/Side Effects             0             1             1             0
Refused trmt Off-study per pt wishes             0             1             1             0
Off study due to missing a vaccine dose             1             0             0             0
Death             0             1             0             0
Progressive disease             9             11             8             14
Other             0             1             0             0
Patient unevaluable due to adverse event             0             0             1             0
Arm/Group Title Colorectal Cancer Cohort Non-Colorectal Cancer Cohort Breast Cohort Ovarian Cohort Total
Hide Arm/Group Description Patients with histologically confirmed measurable or evaluable colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy. Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy. Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy. Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy. Total of all reporting groups
Overall Number of Baseline Participants 10 15 12 14 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  80.0%
12
  80.0%
10
  83.3%
12
  85.7%
42
  82.4%
>=65 years
2
  20.0%
3
  20.0%
2
  16.7%
2
  14.3%
9
  17.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
52.4  (12.2) 57.6  (7.91) 56.5  (11.8) 54.8  (9.0) 55.6  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
Female
4
  40.0%
13
  86.7%
12
 100.0%
14
 100.0%
43
  84.3%
Male
6
  60.0%
2
  13.3%
0
   0.0%
0
   0.0%
8
  15.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
Hispanic or Latino
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Not Hispanic or Latino
9
  90.0%
15
 100.0%
12
 100.0%
14
 100.0%
50
  98.0%
Asian
0
   0.0%
1
   6.7%
1
   8.3%
0
   0.0%
2
   3.9%
Black or African-American
0
   0.0%
1
   6.7%
1
   8.3%
0
   0.0%
2
   3.9%
White
10
 100.0%
12
  80.0%
0
   0.0%
0
   0.0%
22
  43.1%
Unknown or Not Reported
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
   2.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
10
 100.0%
15
 100.0%
12
 100.0%
14
 100.0%
51
 100.0%
Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0-1   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
Grade 0
4
  40.0%
5
  33.3%
2
  16.7%
5
  35.7%
16
  31.4%
Grade 1
6
  60.0%
10
  66.7%
10
  83.3%
9
  64.3%
35
  68.6%
[1]
Measure Description: Grade 0 is normal activity. Fully active, able to carry on all pre-disease performance without restriction. Grade 1 is symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light housework, office work).
Number of Participants with Prior Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
No prior chemotherapy
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
1
   2.0%
Chemotherapy (1 regimen)
2
  20.0%
5
  33.3%
1
   8.3%
1
   7.1%
9
  17.6%
Chemotherapy (2 regimens)
3
  30.0%
6
  40.0%
2
  16.7%
1
   7.1%
12
  23.5%
Chemotherapy (≥3 regimens)
5
  50.0%
4
  26.7%
8
  66.7%
12
  85.7%
29
  56.9%
Radiation
2
  20.0%
3
  20.0%
8
  66.7%
0
   0.0%
13
  25.5%
Number of Participants with a Primary Tumor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 15 participants 12 participants 14 participants 51 participants
Colorectal
10
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
10
  19.6%
Gastric
0
   0.0%
3
  20.0%
0
   0.0%
0
   0.0%
3
   5.9%
Pancreatic
0
   0.0%
2
  13.3%
0
   0.0%
0
   0.0%
2
   3.9%
Appendiceal
0
   0.0%
2
  13.3%
0
   0.0%
0
   0.0%
2
   3.9%
Esophageal adenocarcinoma
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
   2.0%
Ovarian
0
   0.0%
3
  20.0%
0
   0.0%
14
 100.0%
17
  33.3%
Breast
0
   0.0%
2
  13.3%
12
 100.0%
0
   0.0%
14
  27.5%
Lung
0
   0.0%
2
  13.3%
0
   0.0%
0
   0.0%
2
   3.9%
1.Primary Outcome
Title Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts
Hide Description Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all clinical and laboratory signs and symptoms of disease for a minimum of 4 weeks during which no new lesions may appear. Partial Response is a minimum of 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable disease is neither sufficient shrinkage to qualify for partial response nor progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.
Time Frame Approximately 6 months while on trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Breast Cancer Cohort Ovarian Cancer Cohort
Hide Arm/Group Description:
Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.
Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Overall Number of Participants Analyzed 12 14
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   8.3%
0
   0.0%
Partial Response
0
   0.0%
0
   0.0%
Stable Disease
4
  33.3%
3
  21.4%
Progressive Disease
7
  58.3%
11
  78.6%
2.Primary Outcome
Title Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group
Hide Description Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Approximately 6 months while on trial
Hide Outcome Measure Data
Hide Analysis Population Description
The colorectal and non-colorectal cohorts received the same treatment on the same schedule, had no immune dysfunction at baseline and are biologically equivalent. For rare events in small cohorts, a better estimate of the true event rate is determined by grouping similar patients and is consistent with the peer-reviewed clinical paper.
Arm/Group Title Colorectal Cancer and Non-Colorectal Cancer Cohort
Hide Arm/Group Description:
Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer, non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
Overall Number of Participants Analyzed 25
Overall Number of Units Analyzed
Type of Units Analyzed: Vaccines administered
180
Measure Type: Number
Unit of Measure: Percentage of vaccines
Injection-site reaction 88
Fatigue 5
Fever 3
Hemoglobin/Anemia 1
Hypoalbuminemia 1
Alk Phos 1
Syncope 0
Anorexia 1
Vomiting 1
Hot flushes/flashes 1
3.Secondary Outcome
Title Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts
Hide Description Vaccines were administered to participants and Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. Common Terminology Criteria in Adverse Events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Approximately 2 months while on trial
Hide Outcome Measure Data
Hide Analysis Population Description
The breast and ovarian cohorts received the same treatment on the same schedule, had no evidence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small trial arms, the true event rate is better determined by grouping similar patients and is consistent with the peer-reviewed clinical paper.
Arm/Group Title Breast Cancer and Ovarian Cancer Cohorts
Hide Arm/Group Description:
Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
Injection-site reaction 22
Musculoskeletal pain 2
Anemia 1
4.Secondary Outcome
Title Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date consent signed to date off study, approximately 164 months and 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Pts in these 2 cohorts rec'd the same treatment, have absence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small cohorts, a better est. of the true event rate can be determined by grouping the pts in the absence of a biological rationale and is consistent with the peer-reviewed clinical paper.
Arm/Group Title Colorectal Cancer and Non-Colorectal Cancer Cohort Breast Cancer and Ovarian Cancer Cohort
Hide Arm/Group Description:
Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer, non-colorectal cancer, or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
Patients with evaluable, metastatic breast cancer or ovarian cancer who have failed or not a candidate for standard therapy.
Overall Number of Participants Analyzed 25 26
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
26
 100.0%
5.Secondary Outcome
Title Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination
Hide Description Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.
Time Frame post vaccination (up to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed reflects participants that are HLA-A2 positive.
Arm/Group Title Colorectal Cancer Cohort Non-Colorectal Cancer Cohort
Hide Arm/Group Description:
Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.
Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
3
  33.3%
6
  66.7%
6.Secondary Outcome
Title Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination
Hide Description Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.
Time Frame post vaccination (up to Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 Breast Cancer and 2 Ovarian Cancer patients had enough blood collected to perform enzyme-linked immunospot (ELISPOT) analysis.
Arm/Group Title Breast Cancer Cohort Ovarian Cancer Cohort
Hide Arm/Group Description:
Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.
Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Overall Number of Participants Analyzed 3 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
1
  50.0%
Time Frame Date treatment consent signed to date off study, approximately 164 months and 10 days.
Adverse Event Reporting Description Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)*v3.0 if reported prior to August 1, 2010 and CTCAE *v4.0 if reported after.
 
Arm/Group Title Colorectal Cancer vs Non-Colorectal Cancer Cohort Breast and Ovarian Cohorts
Hide Arm/Group Description Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy. Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.
All-Cause Mortality
Colorectal Cancer vs Non-Colorectal Cancer Cohort Breast and Ovarian Cohorts
Affected / at Risk (%) Affected / at Risk (%)
Total   1/25 (4.00%)      0/26 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Colorectal Cancer vs Non-Colorectal Cancer Cohort Breast and Ovarian Cohorts
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/25 (100.00%)      26/26 (100.00%)    
Blood and lymphatic system disorders     
Anemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  8
BLOOD/BONE MARROW:: Hemoglobin*3  1  13/25 (52.00%)  34 8/26 (30.77%)  14
BLOOD/BONE MARROW:: Leukocytes (total WBC)*3  1  4/25 (16.00%)  22 1/26 (3.85%)  3
BLOOD/BONE MARROW:: Lymphopenia*3  1  2/25 (8.00%)  6 1/26 (3.85%)  2
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3  1  5/25 (20.00%)  13 1/26 (3.85%)  4
BLOOD/BONE MARROW:: Platelets*3  1  3/25 (12.00%)  3 2/26 (7.69%)  2
LYMPHATICS:: Edema: limb*3  1  2/25 (8.00%)  2 2/26 (7.69%)  2
COAGULATION:: INR (International Normalized Ratio of prothrombin time)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
COAGULATION:: PTT (Partial Thromboplastin Time)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
LYMPHATICS:: Lymphatics - Other (Edema-Left ankle)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Cardiac disorders     
CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Sinus bradycardia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
CARDIAC ARRHYTHMIA:: Palpitations*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
CARDIAC GENERAL:: Hypotension*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Endocrine disorders     
ENDOCRINE:: Hot flashes/flushes*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
ENDOCRINE:: Thyroid function, low (hypothyroidism)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Eye disorders     
OCULAR/VISUAL:: Keratitis (corneal inflammation/corneal ulceration)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
OCULAR/VISUAL:: Vision-blurred vision*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Eye*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
Gastrointestinal disorders     
Diarrhea*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Anorexia*3  1  5/25 (20.00%)  6 2/26 (7.69%)  2
GASTROINTESTINAL:: Constipation*3  1  3/25 (12.00%)  4 5/26 (19.23%)  6
GASTROINTESTINAL:: Dehydration*3  1  4/25 (16.00%)  4 1/26 (3.85%)  1
GASTROINTESTINAL:: Diarrhea*3  1  5/25 (20.00%)  8 5/26 (19.23%)  9
GASTROINTESTINAL:: Distension/bloating, abdominal*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
GASTROINTESTINAL:: Heartburn/dyspepsia*3  1  6/25 (24.00%)  12 2/26 (7.69%)  3
GASTROINTESTINAL:: Nausea*3  1  5/25 (20.00%)  12 10/26 (38.46%)  13
GASTROINTESTINAL:: Vomiting*3  1  5/25 (20.00%)  9 5/26 (19.23%)  8
Gingival pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Throat/pharynx/larynx*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Vomiting*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Flatulence*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
GASTROINTESTINAL:: Gastrointestinal - Other (Partial bowel obstruction)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
GASTROINTESTINAL:: Obstruction, GI:: Small bowel NOS*3  1  1/25 (4.00%)  6 0/26 (0.00%)  0
GASTROINTESTINAL:: Taste alteration (dysgeusia)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Rectum*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Abdomen NOS*3  1  5/25 (20.00%)  9 6/26 (23.08%)  8
PAIN:: Pain:: Oral cavity*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Stomach*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
GASTROINTESTINAL:: Gastrointestinal - Other (Erythema Mucosa-Under tongue & hard palate)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Gastrointestinal - Other (Gastroesophageal reflux disease )*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
General disorders     
METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  2
CONSTITUTIONAL SYMPTOMS:: Weight gain*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Fever*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Spotting)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Injection site reaction*4  1  0/25 (0.00%)  0 1/26 (3.85%)  4
Non-cardiac chest pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain - Other (Burning sensation waist & tumor area)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  4
SYNDROMES:: Flu-like syndrome*3  1  3/25 (12.00%)  12 18/26 (69.23%)  35
CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms - Other (Cold )*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3  1  13/25 (52.00%)  24 10/26 (38.46%)  20
CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia,  1 [1]  10/25 (40.00%)  14 13/26 (50.00%)  18
CONSTITUTIONAL SYMPTOMS:: Insomnia*3  1  1/25 (4.00%)  2 2/26 (7.69%)  2
CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3  1  12/25 (48.00%)  14 3/26 (11.54%)  4
CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3  1  4/25 (16.00%)  5 2/26 (7.69%)  4
CONSTITUTIONAL SYMPTOMS:: Weight loss*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
DEATH:: Death not associated with CTCAE term:: Disease progression NOS*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
PAIN:: Pain:: Pain NOS*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Right inguinal pain)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain - Other (Rt. thigh pain)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  2
PAIN:: Pain - Other (Sternum pain)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain - Other (Pain-Upper right quadrant)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Rt. flank)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Rt. ear)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Pain from inserted biliary stents)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Hepatobiliary disorders     
HEPATOBILIARY/PANCREAS:: Pancreatitis*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Immune system disorders     
Allergic reaction*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3  1  2/25 (8.00%)  4 4/26 (15.38%)  6
Infections and infestations     
INFECTION:: Infection - Other (Lt. lower leg, redness, swelling, & whelts)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Wound infection*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
INFECTION:: Infection with unknown ANC:: Urinary tract NOS*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
INFECTION:: Infection with unknown ANC:: Wound*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Fall*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Wound dehiscence*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
Investigations     
Activated partial thromboplastin time prolonged*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Alanine aminotransferase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  5
Alkaline phosphatase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Aspartate aminotransferase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  6
CPK increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Creatinine increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Investigations - Other, specify*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Lipase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Lymphocyte count decreased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  9
Neutrophil count decreased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Weight gain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
Metabolism and nutrition disorders     
Hyperglycemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  5
Hypernatremia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hyperuricemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hypoalbuminemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  3
Hypocalcemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  3
Hypoglycemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hypokalemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hypomagnesemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  4
Hyponatremia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
Hypophosphatemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  5
METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Hemoglobinuria*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3  1  8/25 (32.00%)  18 2/26 (7.69%)  2
METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3  1  7/25 (28.00%)  12 8/26 (30.77%)  8
METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3  1  15/25 (60.00%)  26 20/26 (76.92%)  25
METABOLIC/LABORATORY:: Alkaline phosphatase*3  1  8/25 (32.00%)  10 5/26 (19.23%)  6
METABOLIC/LABORATORY:: Amylase*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Bicarbonate, serum-low*3  1  2/25 (8.00%)  5 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3  1  8/25 (32.00%)  12 3/26 (11.54%)  3
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3  1  2/25 (8.00%)  2 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3  1  5/25 (20.00%)  7 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3  1  5/25 (20.00%)  7 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Creatinine*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
METABOLIC/LABORATORY:: GGT (gamma-Glutamyl transpeptidase)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3  1  9/25 (36.00%)  11 5/26 (19.23%)  5
METABOLIC/LABORATORY:: Lipase*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3  1  3/25 (12.00%)  3 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3  1  4/25 (16.00%)  11 5/26 (19.23%)  9
METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3  1  2/25 (8.00%)  3 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3  1  2/25 (8.00%)  3 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Proteinuria*3  1  4/25 (16.00%)  4 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3  1  7/25 (28.00%)  10 4/26 (15.38%)  4
METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3  1  5/25 (20.00%)  14 2/26 (7.69%)  2
Musculoskeletal and connective tissue disorders     
Back pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area  1 [2]  0/25 (0.00%)  0 3/26 (11.54%)  4
Neck pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Chest/thorax NOS*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Back*3  1  10/25 (40.00%)  11 5/26 (19.23%)  6
PAIN:: Pain:: Bone*3  1  3/25 (12.00%)  3 2/26 (7.69%)  2
PAIN:: Pain:: Chest wall*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
PAIN:: Pain:: Extremity-limb*3  1  6/25 (24.00%)  6 4/26 (15.38%)  4
PAIN:: Pain:: Joint*3  1  4/25 (16.00%)  5 0/26 (0.00%)  0
PAIN:: Pain:: Muscle*3  1  12/25 (48.00%)  20 4/26 (15.38%)  4
PAIN:: Pain:: Neck*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
Nervous system disorders     
Headache*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
NEUROLOGY:: Mood alteration:: Agitation*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
NEUROLOGY:: Neuropathy: motor*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders - Other, specify*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Peripheral motor neuropathy*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
NEUROLOGY:: Dizziness*3  1  5/25 (20.00%)  8 1/26 (3.85%)  2
NEUROLOGY:: Mood alteration:: Anxiety*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
NEUROLOGY:: Mood alteration:: Depression*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
NEUROLOGY:: Neuropathy: cranial:: CN I Smell*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
NEUROLOGY:: Neuropathy: cranial:: CN VIII Hearing and balance*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
NEUROLOGY:: Syncope (fainting)*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
PAIN:: Pain:: Head/headache*3  1  12/25 (48.00%)  20 11/26 (42.31%)  17
Psychiatric disorders     
Delirium*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Depression*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hallucinations*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders     
Cystitis noninfective*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Nasal congestion*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Bladder*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
RENAL/GENITOURINARY:: Bladder spasms*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
RENAL/GENITOURINARY:: Renal/Genitourinary - Other (Dysuria)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
RENAL/GENITOURINARY:: Urinary frequency/urgency*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
Reproductive system and breast disorders     
PAIN:: Pain:: Pelvis*3  1  0/25 (0.00%)  0 3/26 (11.54%)  3
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Pleural effusion*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PULMONARY/UPPER RESPIRATORY:: Cough*3  1  5/25 (20.00%)  6 7/26 (26.92%)  9
PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3  1  1/25 (4.00%)  1 2/26 (7.69%)  3
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Allergic reaction-Tape)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
DERMATOLOGY/SKIN:: Dry skin*3  1  0/25 (0.00%)  0 2/26 (7.69%)  2
DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3  1  0/25 (0.00%)  0 23/26 (88.46%)  83
Pruritus*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
DERMATOLOGY/SKIN:: Induration/fibrosis (skin and subcutaneous tissue)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3  1  25/25 (100.00%)  146 23/26 (88.46%)  83
DERMATOLOGY/SKIN:: Nail changes*3  1  1/25 (4.00%)  1 5/26 (19.23%)  5
DERMATOLOGY/SKIN:: Pruritus/itching*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
DERMATOLOGY/SKIN:: Rash/desquamation*3  1  2/25 (8.00%)  4 1/26 (3.85%)  1
Dermatology/Skin - Other (Mouth sore-lower lip)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures     
Surgical and medical procedures - Other, specify*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
where neutropenia is defined as ANC <1.0 x 10e9/L)*3
[2]
(not due to neuropathy):: Whole body/generalized*3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colorectal Cancer vs Non-Colorectal Cancer Cohort Breast and Ovarian Cohorts
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/25 (100.00%)      26/26 (100.00%)    
Blood and lymphatic system disorders     
Anemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
BLOOD/BONE MARROW:: Hemoglobin*3  1  13/25 (52.00%)  34 1/26 (3.85%)  1
BLOOD/BONE MARROW:: Leukocytes (total WBC)*3  1  4/25 (16.00%)  22 8/26 (30.77%)  14
BLOOD/BONE MARROW:: Lymphopenia*3  1  2/25 (8.00%)  6 1/26 (3.85%)  3
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3  1  5/25 (20.00%)  13 1/26 (3.85%)  2
BLOOD/BONE MARROW:: Platelets*3  1  3/25 (12.00%)  3 1/26 (3.85%)  4
LYMPHATICS:: Edema: limb*3  1  2/25 (8.00%)  2 1/26 (3.85%)  4
COAGULATION:: INR (International Normalized Ratio of prothrombin time)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
COAGULATION:: PTT (Partial Thromboplastin Time)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
LYMPHATICS:: Lymphatics - Other (Edema-left ankle)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Cardiac disorders     
CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Sinus bradycardia*4  1  0/25 (0.00%)  0 18/26 (69.23%)  35
CARDIAC ARRHYTHMIA:: Palpitations*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
CARDIAC GENERAL:: Hypotension*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Endocrine disorders     
ENDOCRINE:: Hot flashes/flushes*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
ENDOCRINE:: Thyroid function, low (hypothyroidism)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Eye disorders     
PAIN:: Pain:: Eye*3  1  1/25 (4.00%)  1 4/26 (15.38%)  4
Eye disorders - Other, specify  1  0/25 (0.00%)  0 1/26 (3.85%)  1
OCULAR/VISUAL:: Keratitis (corneal inflammation/corneal ulceration)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
OCULAR/VISUAL:: Vision-blurred vision*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Gastrointestinal disorders     
Diarrhea*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Anorexia*3  1  5/25 (20.00%)  6 1/26 (3.85%)  1
GASTROINTESTINAL:: Constipation*3  1  3/25 (12.00%)  4 2/26 (7.69%)  2
GASTROINTESTINAL:: Diarrhea*3  1  5/25 (20.00%)  8 5/26 (19.23%)  6
GASTROINTESTINAL:: Distension/bloating, abdominal*3  1  2/25 (8.00%)  2 5/26 (19.23%)  9
GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
GASTROINTESTINAL:: Heartburn/dyspepsia*3  1  6/25 (24.00%)  12 4/26 (15.38%)  4
GASTROINTESTINAL:: Nausea*3  1  5/25 (20.00%)  12 2/26 (7.69%)  3
GASTROINTESTINAL:: Vomiting*3  1  5/25 (20.00%)  9 10/26 (38.46%)  13
Gingival pain*4  1  0/25 (0.00%)  0 5/26 (19.23%)  8
PAIN:: Pain:: Abdomen NOS*3  1  5/25 (20.00%)  9 3/26 (11.54%)  5
PAIN:: Pain:: Stomach*3  1  2/25 (8.00%)  2 3/26 (11.54%)  3
Vomiting*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Dehydration*3  1  3/25 (12.00%)  3 0/26 (0.00%)  0
GASTROINTESTINAL:: Flatulence*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
GASTROINTESTINAL:: Obstruction, GI:: Small bowel NOS*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
GASTROINTESTINAL:: Taste alteration (dysgeusia)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Rectum*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Oral cavity*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
GASTROINTESTINAL:: Gastrointestinal - Other (Erythema mucosa-under tongue & hard palate )*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Gastrointestinal - Other (Gastroesophageal reflux disease)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
GASTROINTESTINAL:: Gastrointestinal - Other (Partial bowel obstruction)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
General disorders     
CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3  1  13/25 (52.00%)  24 1/26 (3.85%)  1
CONSTITUTIONAL SYMPTOMS  1 [1]  0/25 (0.00%)  0 10/26 (38.46%)  20
CONSTITUTIONAL SYMPTOMS:: Insomnia*3  1  1/25 (4.00%)  2 13/26 (50.00%)  18
CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3  1  12/25 (48.00%)  14 2/26 (7.69%)  2
CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3  1  4/25 (16.00%)  5 3/26 (11.54%)  4
CONSTITUTIONAL SYMPTOMS:: Weight gain*3  1  0/25 (0.00%)  0 2/26 (7.69%)  4
Fever*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Spotting )*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Injection site reaction*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Non-cardiac chest pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain - Other (Burning sensation waist & tumor area)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
SYNDROMES:: Flu-like syndrome*3  1  3/25 (12.00%)  12 1/26 (3.85%)  1
CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms - Other (Cold)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as ANC  1 [2]  10/25 (40.00%)  14 0/26 (0.00%)  0
CONSTITUTIONAL SYMPTOMS:: Weight loss*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Pain-upper right quadrant)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Joint*3  1  4/25 (16.00%)  5 0/26 (0.00%)  0
PAIN:: Pain:: Pain NOS*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Right inguinal pain)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain - Other (Rt. thigh pain)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  2
PAIN:: Pain - Other (Sternum pain)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain - Other (Rt. flank)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Rt. ear)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain - Other (Pain from inserted biliary stents)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Immune system disorders     
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3  1  2/25 (8.00%)  4 1/26 (3.85%)  2
Allergic reaction*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations     
INFECTION:: Infection - Other (Lt. lower leg, redness, swelling & whelts)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
Lipase increased*4  1  0/25 (0.00%)  0 2/26 (7.69%)  2
Wound infection*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
INFECTION:: Infection with unknown ANC:: Urinary tract NOS*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Fall*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Wound dehiscence*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
Investigations     
Activated partial thromboplastin time prolonged*4  1  0/25 (0.00%)  0 4/26 (15.38%)  6
Alanine aminotransferase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Alkaline phosphatase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Aspartate aminotransferase increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  6
CPK increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Creatinine increased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Lymphocyte count decreased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Neutrophil count decreased*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Weight gain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Metabolism and nutrition disorders     
Hyperglycemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hyperuricemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  5
Hypoalbuminemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hypoglycemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
Hypomagnesemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hypophosphatemia*4  1  0/25 (0.00%)  0 1/26 (3.85%)  4
METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3  1  8/25 (32.00%)  18 1/26 (3.85%)  9
METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3  1  7/25 (28.00%)  12 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3  1  15/25 (60.00%)  26 8/26 (30.77%)  8
METABOLIC/LABORATORY:: Alkaline phosphatase*3  1  8/25 (32.00%)  10 20/26 (76.92%)  25
METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3  1  8/25 (32.00%)  12 5/26 (19.23%)  6
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3  1  2/25 (8.00%)  2 3/26 (11.54%)  3
METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3  1  5/25 (20.00%)  7 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3  1  3/25 (12.00%)  7 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3  1  9/25 (36.00%)  11 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)*3  1  0/25 (0.00%)  0 5/26 (19.23%)  5
METABOLIC/LABORATORY:: Hemoglobinuria*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3  1  3/25 (12.00%)  3 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3  1  4/25 (16.00%)  11 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3  1  2/25 (8.00%)  2 5/26 (19.23%)  9
METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3  1  2/25 (8.00%)  3 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3  1  2/25 (8.00%)  3 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Proteinuria*3  1  4/25 (16.00%)  4 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)*3  1  0/25 (0.00%)  0 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3  1  7/25 (28.00%)  10 1/26 (3.85%)  1
METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3  1  5/25 (20.00%)  14 4/26 (15.38%)  4
MUSCULOSKELETAL/SOFT TISSUE  1 [3]  0/25 (0.00%)  0 2/26 (7.69%)  2
METABOLIC/LABORATORY:: Amylase*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Bicarbonate, serum-low*3  1  2/25 (8.00%)  5 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Creatinine*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
METABOLIC/LABORATORY:: GGT (gamma-Glutamyl transpeptidase)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
METABOLIC/LABORATORY:: Lipase*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain*4  1  0/25 (0.00%)  0 2/26 (7.69%)  2
Neck pain*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Back*3  1  10/25 (40.00%)  11 6/26 (23.08%)  8
PAIN:: Pain:: Bone*3  1  3/25 (12.00%)  3 5/26 (19.23%)  6
PAIN:: Pain:: Chest wall*3  1  1/25 (4.00%)  1 2/26 (7.69%)  2
PAIN:: Pain:: Chest/thorax NOS*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Extremity-limb*3  1  6/25 (24.00%)  6 1/26 (3.85%)  1
PAIN:: Pain:: Muscle*3  1  12/25 (48.00%)  20 11/26 (42.31%)  17
PAIN:: Pain:: Neck*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
Nervous system disorders     
Headache*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
NEUROLOGY:: Dizziness*3  1  5/25 (20.00%)  8 3/26 (11.54%)  4
NEUROLOGY:: Mood alteration:: Agitation*3  1  0/25 (0.00%)  0 1/26 (3.85%)  2
NEUROLOGY:: Mood alteration:: Depression*3  1  1/25 (4.00%)  1 1/26 (3.85%)  1
NEUROLOGY:: Neuropathy: motor*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders - Other, specify*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Head/headache*3  1  12/25 (48.00%)  20 1/26 (3.85%)  1
Peripheral motor neuropathy*4  1  0/25 (0.00%)  0 1/26 (3.85%)  2
NEUROLOGY:: Mood alteration:: Anxiety*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
NEUROLOGY:: Neuropathy: cranial:: CN I Smell*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
NEUROLOGY:: Neuropathy: cranial:: CN VIII Hearing and balance*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
NEUROLOGY:: Syncope (fainting)*3  1  2/25 (8.00%)  2 0/26 (0.00%)  0
Psychiatric disorders     
Delirium*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Depression*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Hallucinations*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders     
Cystitis noninfective*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
RENAL/GENITOURINARY:: Urinary frequency/urgency*3  1  2/25 (8.00%)  2 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PAIN:: Pain:: Bladder*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
RENAL/GENITOURINARY:: Bladder spasms*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
RENAL/GENITOURINARY:: Renal/Genitourinary - Other (Dysuria)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Reproductive system and breast disorders     
PAIN:: Pain:: Pelvis*3  1  0/25 (0.00%)  0 4/26 (15.38%)  4
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Nasal congestion*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PAIN:: Pain:: Throat/pharynx/larynx*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
PULMONARY/UPPER RESPIRATORY:: Cough*3  1  5/25 (20.00%)  6 1/26 (3.85%)  1
PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3  1  1/25 (4.00%)  1 7/26 (26.92%)  9
PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Allergic reaction-Tape )*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
DERMATOLOGY/SKIN:: Dry skin*3  1  0/25 (0.00%)  0 1/26 (3.85%)  2
DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3  1  25/25 (100.00%)  146 2/26 (7.69%)  2
DERMATOLOGY/SKIN:: Pruritus/itching*3  1  1/25 (4.00%)  1 23/26 (88.46%)  83
DERMATOLOGY/SKIN:: Rash/desquamation*3  1  2/25 (8.00%)  4 5/26 (19.23%)  5
Pruritus*4  1  0/25 (0.00%)  0 1/26 (3.85%)  1
DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)*3  1  1/25 (4.00%)  2 0/26 (0.00%)  0
DERMATOLOGY/SKIN:: Induration/fibrosis (skin and subcutaneous tissue)*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
DERMATOLOGY/SKIN:: Nail changes*3  1  1/25 (4.00%)  1 0/26 (0.00%)  0
DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Mouth sore-lower lip)*3  1  0/25 (0.00%)  0 1/26 (3.85%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)*3
[2]
<1.0 x 10e9/L)*3
[3]
Muscle weakness, generalized or specific area (not due to neuropathy):: Whole body/generalized*3
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
Layout table for Results Point of Contact information
Name/Title: Dr. James Gulley
Organization: National Cancer Institute
Phone: 301-480-8870
EMail: james_gulley@nih.gov
Layout table for additonal information
Responsible Party: James Gulley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00088413     History of Changes
Obsolete Identifiers: NCT00091000
Other Study ID Numbers: 040246
04-C-0246
First Submitted: July 23, 2004
First Posted: July 26, 2004
Results First Submitted: September 14, 2018
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019