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Trial record 31 of 164 for:    PEMT

Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer

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: NCT00179309
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : June 27, 2013
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
James Gulley, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Docetaxel
Biological: PANVAC-V
Biological: PANVAC-F
Biological: Sargramostim
Enrollment 48
Recruitment Details  
Pre-assignment Details Crossover was allowed so that patients randomized to B could receive the vaccine upon progression.
Arm/Group Title Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Hide Arm/Group Description

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.

PANVAC-V: given subcutaneously

Sargramostim : given subcutaneously (NCI subjects only)

PANVAC-F : given subcutaneously

Docetaxel : given IV

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

Docetaxel : given intravenous (IV)

Period Title: Treatment
Started 25 23
Completed 21 18
Not Completed 4 5
Reason Not Completed
Toxicity             2             3
Withdrawal by Subject             1             2
Allergy             1             0
Period Title: Crossover
Started 0 3 [1]
Completed 0 3
Not Completed 0 0
[1]
Crossover was allowed so that patients randomized to B could receive the vaccine upon progression.
Arm/Group Title Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone Total
Hide Arm/Group Description

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.

PANVAC-V : given subcutaneously

Sargramostim : given subcutaneously (NCI subjects only)

PANVAC-F : given subcutaneously

Docetaxel : given IV

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

Docetaxel : given intravenous (IV)

Total of all reporting groups
Overall Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  80.0%
18
  78.3%
38
  79.2%
>=65 years
5
  20.0%
5
  21.7%
10
  20.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 23 participants 48 participants
55.52  (10.52) 53.01  (12.22) 54.31  (11.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
25
 100.0%
22
  95.7%
47
  97.9%
Male
0
   0.0%
1
   4.3%
1
   2.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Hispanic or Latino
0
   0.0%
3
  13.0%
3
   6.3%
Not Hispanic or Latino
25
 100.0%
20
  87.0%
45
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
2
   8.7%
3
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  28.0%
3
  13.0%
10
  20.8%
White
17
  68.0%
18
  78.3%
35
  72.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 23 participants 48 participants
25 23 48
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.
Time Frame 19.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Hide Arm/Group Description:

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.

PANVAC-V : given subcutaneously

Sargramostim : given subcutaneously (NCI subjects only)

PANVAC-F : given subcutaneously

Docetaxel : given IV

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

Docetaxel : given intravenous (IV)

Overall Number of Participants Analyzed 25 23
Median (95% Confidence Interval)
Unit of Measure: Months
6.6
(3.7 to 9.4)
3.8
(2.6 to 8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - PANVAC + Docetaxel
Comments 48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Multiple comparisons were not done.
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 80 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Hide Arm/Group Description:

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.

PANVAC-V : given subcutaneously

Sargramostim : given subcutaneously (NCI subjects only)

PANVAC-F : given subcutaneously

Docetaxel : given IV

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

Docetaxel : given intravenous (IV)

Overall Number of Participants Analyzed 25 23
Measure Type: Number
Unit of Measure: Participants
23 23
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Hide Arm/Group Description

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.

PANVAC-V : given subcutaneously

Sargramostim : given subcutaneously (NCI subjects only)

PANVAC-F : given subcutaneously

Docetaxel : given IV

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

Docetaxel : given intravenous (IV)

All-Cause Mortality
Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      2/23 (8.70%)    
Blood and lymphatic system disorders     
Anemia  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Cardiac disorders     
Sinus tachycardia  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Pericardial effusion  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal disorders - Other, specify -stomatitis)  1  0/25 (0.00%)  0 1/23 (4.35%)  2
Vomiting  1  1/25 (4.00%)  1 0/23 (0.00%)  0
General disorders     
Fever  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Injection site reaction  1  1/25 (4.00%)  1 1/23 (4.35%)  1
Infections and infestations     
Catheter related infection  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Investigations     
Activated partial thromboplastin time prolonged  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Hyponatremia  1  1/25 (4.00%)  2 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Nervous system disorders     
Nervous system disorders - Other, specify -neuropathy, hands and feet  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Psychiatric disorders     
Confusion  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Delirium  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Pleural effusion  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Vascular disorders     
Hypotension  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Thromboembolic event  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Vascular access complication  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I - PANVAC + Docetaxel Arm II - Docetaxel Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      23/23 (100.00%)    
Blood and lymphatic system disorders     
Edema face  1  3/25 (12.00%)  3 1/23 (4.35%)  1
Edema limbs  1  10/25 (40.00%)  13 2/23 (8.70%)  2
Anemia  1  14/25 (56.00%)  56 10/23 (43.48%)  43
Blood and lymphatic system disorders - Other, specify (hemoglobin, decreased)  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Blood and lymphatic system disorders - Other, specify (anemia; hemoglobin decreased))  1  0/25 (0.00%)  0 3/23 (13.04%)  5
Cardiac disorders     
Cardiac disorders - Other, specify (tachycardia)  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Pericardial effusion  1  4/25 (16.00%)  5 0/23 (0.00%)  0
Sinus tachycardia  1  2/25 (8.00%)  3 2/23 (8.70%)  4
Cardiac troponin I increased  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Palpitations  1  2/25 (8.00%)  3 0/23 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Ear pain  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Eye disorders     
Cataract  1  2/25 (8.00%)  3 0/23 (0.00%)  0
Eyelid function disorder  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Blurred vision  1  1/25 (4.00%)  1 1/23 (4.35%)  2
Dry eye  1  1/25 (4.00%)  1 1/23 (4.35%)  1
Watering eyes  1  12/25 (48.00%)  15 9/23 (39.13%)  10
Eye disorders - Other, specify (eye disorder: twitch; eye tearing)  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Eye disorders - Other, specify (eye tearing; eye tearing, watery eyes; eye redness))  1  0/25 (0.00%)  0 3/23 (13.04%)  3
Gastrointestinal disorders     
Anorexia  1  5/25 (20.00%)  10 4/23 (17.39%)  5
Constipation  1  5/25 (20.00%)  7 8/23 (34.78%)  11
Dental caries  1  1/25 (4.00%)  1 1/23 (4.35%)  1
Diarrhea  1  10/25 (40.00%)  23 9/23 (39.13%)  27
Dry mouth  1  2/25 (8.00%)  3 0/23 (0.00%)  0
Dyspepsia  1  1/25 (4.00%)  5 3/23 (13.04%)  3
Gastrointestinal disorders - Other, specify (stomatitis)  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Nausea  1  10/25 (40.00%)  16 7/23 (30.43%)  21
Abdominal pain  1  1/25 (4.00%)  2 2/23 (8.70%)  2
Dysgeusia  1  8/25 (32.00%)  9 4/23 (17.39%)  6
Vomiting  1  6/25 (24.00%)  12 4/23 (17.39%)  7
Mucositis oral  1  6/25 (24.00%)  7 4/23 (17.39%)  6
Gingival pain  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Gastritis  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Gastroesophageal reflux disease  1  0/25 (0.00%)  0 2/23 (8.70%)  3
Oral pain  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Periodontal disease  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Stomach pain  1  0/25 (0.00%)  0 1/23 (4.35%)  1
General disorders     
Fatigue  1  16/25 (64.00%)  49 15/23 (65.22%)  29
Fever  1  5/25 (20.00%)  5 6/23 (26.09%)  13
Flu-like syndrome  1  3/25 (12.00%)  3 4/23 (17.39%)  4
Pain  1  6/25 (24.00%)  9 2/23 (8.70%)  5
Chills  1  2/25 (8.00%)  5 1/23 (4.35%)  1
General disorders and administration site conditions - Other, specify  1 [1]  4/25 (16.00%)  5 0/23 (0.00%)  0
Infusion site extravasation  1  1/25 (4.00%)  1 0/23 (0.00%)  0
General disorders and administration site conditions - Other, specify  1 [2]  0/25 (0.00%)  0 3/23 (13.04%)  3
Immune system disorders     
Allergic reaction  1  3/25 (12.00%)  4 0/23 (0.00%)  0
Infections and infestations     
Skin infection  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Nail infection  1  1/25 (4.00%)  2 1/23 (4.35%)  1
Paronychia  1  1/25 (4.00%)  2 1/23 (4.35%)  1
Urinary tract infection  1  3/25 (12.00%)  3 3/23 (13.04%)  4
Infections and infestations - Other, specify (left middle finger; port infection)  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Sinusitis  1  1/25 (4.00%)  1 2/23 (8.70%)  2
Tooth infection  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Infections and infestations - Other, specify (upper respiratiry infection)  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Wound infection  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Investigations     
Lymphocyte count decreased  1  11/25 (44.00%)  49 13/23 (56.52%)  41
Alanine aminotransaminase increased  1  7/25 (28.00%)  15 9/23 (39.13%)  18
Aspartate aminotransaminase increased  1  9/25 (36.00%)  25 9/23 (39.13%)  19
Alkaline phosphatase increased  1  8/25 (32.00%)  14 4/23 (17.39%)  8
Blood bilirubin increased  1  1/25 (4.00%)  2 4/23 (17.39%)  8
CPK increased  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Creatinine increased  1  3/25 (12.00%)  8 0/23 (0.00%)  0
Neutrophil count decreased  1  10/25 (40.00%)  39 6/23 (26.09%)  9
Activated partial thromboplastin time prolonged  1  1/25 (4.00%)  1 1/23 (4.35%)  3
Cholesterol high  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Platelet count decreased  1  4/25 (16.00%)  7 2/23 (8.70%)  2
Weight loss  1  1/25 (4.00%)  2 1/23 (4.35%)  1
Investigations - Other, specify (elevated LDH)  1  1/25 (4.00%)  7 0/23 (0.00%)  0
CD4 lymphocytes decreased  1  1/25 (4.00%)  1 1/23 (4.35%)  4
White blood cell decreased  1  10/25 (40.00%)  59 11/23 (47.83%)  23
Fibrinogen decreased  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Investigations - Other, specify  1 [3]  0/25 (0.00%)  0 3/23 (13.04%)  6
Weight gain  1  0/25 (0.00%)  0 1/23 (4.35%)  2
Metabolism and nutrition disorders     
Hypercalcemia  1  4/25 (16.00%)  5 2/23 (8.70%)  6
Dehydration  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Hyperglycemia  1  12/25 (48.00%)  45 13/23 (56.52%)  38
Hypermagnesemia  1  3/25 (12.00%)  4 3/23 (13.04%)  4
Hypomagnesemia  1  3/25 (12.00%)  9 0/23 (0.00%)  0
Hypophosphatemia  1  2/25 (8.00%)  2 3/23 (13.04%)  9
Hyperkalemia  1  4/25 (16.00%)  6 1/23 (4.35%)  1
Hypokalemia  1  2/25 (8.00%)  2 4/23 (17.39%)  6
Hyponatremia  1  6/25 (24.00%)  9 5/23 (21.74%)  12
Hyperuricemia  1  3/25 (12.00%)  3 1/23 (4.35%)  4
Hypoalbuminemia  1  14/25 (56.00%)  48 10/23 (43.48%)  32
Hypoglycemia  1  1/25 (4.00%)  1 1/23 (4.35%)  1
Hypocalcemia  1  0/25 (0.00%)  0 3/23 (13.04%)  6
Metabolism and nutrition disorders - Other, specify  1 [4]  0/25 (0.00%)  0 3/23 (13.04%)  13
Musculoskeletal and connective tissue disorders     
Gait disturbance  1  1/25 (4.00%)  3 0/23 (0.00%)  0
Myalgia  1  3/25 (12.00%)  7 2/23 (8.70%)  4
Musculoskeletal and connective tissue disorder - Other, specify  1 [5]  1/25 (4.00%)  1 0/23 (0.00%)  0
Pain in extremity  1  1/25 (4.00%)  2 3/23 (13.04%)  4
Arthralgia  1  4/25 (16.00%)  6 3/23 (13.04%)  3
Back pain  1  2/25 (8.00%)  6 1/23 (4.35%)  1
Bone pain  1  1/25 (4.00%)  2 2/23 (8.70%)  2
Buttock pain  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Muscle weakness lower limb  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Non-cardiac chest pain  1  2/25 (8.00%)  3 0/23 (0.00%)  0
Chest wall pain  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Muscle weakness upper limb  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1 [6]  0/25 (0.00%)  0 2/23 (8.70%)  3
Nervous system disorders     
Dizziness  1  4/25 (16.00%)  16 2/23 (8.70%)  2
Tremor  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Facial nerve disorder  1  1/25 (4.00%)  1 1/23 (4.35%)  1
Headache  1  2/25 (8.00%)  15 3/23 (13.04%)  9
Nervous system disorders - Other, specify-neuropathy; neuropathy: toes; Rt finger tip numbness)  1  5/25 (20.00%)  5 0/23 (0.00%)  0
Paresthesia  1  4/25 (16.00%)  5 5/23 (21.74%)  5
Peripheral sensory neuropathy  1  7/25 (28.00%)  14 6/23 (26.09%)  7
Psychiatric disorders     
Psychosis  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Depression  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Anxiety  1  0/25 (0.00%)  0 1/23 (4.35%)  2
Insomnia  1  0/25 (0.00%)  0 2/23 (8.70%)  2
Renal and urinary disorders     
Hemoglobinuria  1  2/25 (8.00%)  2 1/23 (4.35%)  1
Hematuria  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Proteinuria  1  5/25 (20.00%)  8 4/23 (17.39%)  4
Reproductive system and breast disorders     
Reproductive system and breast disorders - Other, specify (dyspareunia)  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Vaginal hemorrhage  1  0/25 (0.00%)  0 1/23 (4.35%)  2
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  4/25 (16.00%)  4 4/23 (17.39%)  4
Cough  1  6/25 (24.00%)  10 5/23 (21.74%)  7
Dyspnea  1  8/25 (32.00%)  21 4/23 (17.39%)  5
Hypoxia  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Pleural effusion  1  7/25 (28.00%)  9 4/23 (17.39%)  5
Voice alteration  1  2/25 (8.00%)  2 1/23 (4.35%)  1
Epistaxis  1  4/25 (16.00%)  8 1/23 (4.35%)  1
Nasal congestion  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Pharyngolaryngeal pain  1  2/25 (8.00%)  2 2/23 (8.70%)  2
Laryngeal inflammation  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify (rhinorrhea)  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Sore throat  1  0/25 (0.00%)  0 3/23 (13.04%)  3
Upper respiratory infection  1  0/25 (0.00%)  0 2/23 (8.70%)  4
Wheezing  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Skin and subcutaneous tissue disorders     
Injection site reaction  1  17/25 (68.00%)  114 3/23 (13.04%)  7
Alopecia  1  15/25 (60.00%)  18 13/23 (56.52%)  13
Skin hyperpigmentation  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [7]  3/25 (12.00%)  4 0/23 (0.00%)  0
Pruritis  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Rash acneiform  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Skin ulceration  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Dry skin  1  2/25 (8.00%)  2 1/23 (4.35%)  1
Metabolism and nutrition disorders - Other, specify  1 [8]  1/25 (4.00%)  5 0/23 (0.00%)  0
Nail discoloration  1  3/25 (12.00%)  4 3/23 (13.04%)  3
Nail loss  1  6/25 (24.00%)  6 5/23 (21.74%)  5
Nail ridging  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Palmer-plantar erythrodysesthesia syndrome  1  1/25 (4.00%)  1 2/23 (8.70%)  2
Rash maculo-papular  1  6/25 (24.00%)  8 3/23 (13.04%)  4
Skin induration  1  2/25 (8.00%)  2 0/23 (0.00%)  0
Hyperhidrosis  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Skin and subcutaneous tissue disorders - Other, specify  1 [9]  0/25 (0.00%)  0 3/23 (13.04%)  8
Surgical and medical procedures     
Surgical and medical procedures - Other, specify (surgical procedure, internal fixation)  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Vascular disorders     
Vascular disorders - Other, specify (Rt side eye; subconj. hem)  1  1/25 (4.00%)  1 0/23 (0.00%)  0
Flushing  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Hot flashes  1  0/25 (0.00%)  0 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
body aches; decrease in taste; drowsiness; loss of taste; stomatitis
[2]
stomatitis the patient had a cold
[3]
neutrophil count decreased; white blood cells decreased; BUN decreased 7mg/dL; bicarbonate, serum low; creatine kinase increased 22 mg/dl; lymphocyte count decreased
[4]
albumin decreased; creatinine kinase decreased; creatinine decreased; creatine decreased; hemoglobin decreased; iron decreased; potassium decreased; sodium decreased; sodium increased; total protein, low
[5]
muscle spasm, back, lt. foot/toe, jaw
[6]
muscle spasm; musculoskeletal and connective tissue disorder - other, specify: toe cramp; myalgia/arthralgia (knee pain)
[7]
extravasation lt. forearm extravasation - infusion site lt. arm skin - annular quarter sized raised, red, uncomfortable at previous Denver insertion site
[8]
albumin decreased; BUN, decreased; bilirubin increased
[9]
big toes and thumbs; general itching; peeling hands; rash (interior ankles); redden area at base of neck
The goal of this study was to get preliminary evidence of improved progression free survival with the combination compared with docetaxel alone and obtain data on which to plan a larger more definitive study in a more uniform patient population.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. James Gulley, M.D., Ph.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-435-2956
Responsible Party: James Gulley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00179309     History of Changes
Obsolete Identifiers: NCT00217750
Other Study ID Numbers: 050229
05-C-0229
First Submitted: September 15, 2005
First Posted: September 15, 2005
Results First Submitted: April 29, 2013
Results First Posted: June 27, 2013
Last Update Posted: July 15, 2014