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Trial record 7 of 2029 for:    doxil

A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced 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: NCT00091442
Recruitment Status : Completed
First Posted : September 13, 2004
Results First Posted : October 2, 2012
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Docetaxel
Drug: DOXIL
Enrollment 751
Recruitment Details A total of 751 participants were enrolled and randomized at 143 sites in 19 countries.
Pre-assignment Details 751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.
Arm/Group Title Docetaxel DOXIL+Docetaxel
Hide Arm/Group Description Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Period Title: Overall Study
Started 373 378
Completed 4 [1] 5 [1]
Not Completed 369 373
Reason Not Completed
Progressive Disease             220             189
Physician Decision             61             58
Withdrawal by Subject             38             46
Adverse Event             29             48
2cycles therapy beyond Complete response             9             16
Death             9             7
Lost to Follow-up             1             3
Not Specified             2             6
[1]
Indicates number of participants on study treatment at time of the primary objective
Arm/Group Title Docetaxel DOXIL+Docetaxel Total
Hide Arm/Group Description Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 373 378 751
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 373 participants 378 participants 751 participants
52.0  (9.23) 52.8  (9.17) 52.4  (9.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 378 participants 751 participants
Female
373
 100.0%
378
 100.0%
751
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Time to Progression
Hide Description Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
Time Frame From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.
Arm/Group Title Docetaxel DOXIL+Docetaxel
Hide Arm/Group Description:
Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Overall Number of Participants Analyzed 373 378
Median (95% Confidence Interval)
Unit of Measure: Months
7.0
(5.9 to 7.7)
9.8
(8.1 to 10.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, DOXIL+Docetaxel
Comments

Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.

Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval 95%
0.55 to 0.77
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Time interval in months between the date of randomization and the participant's death from any cause.
Time Frame From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: If the date of death was unknown, the data were censored at the date that the participant was last known to have been alive.
Arm/Group Title Docetaxel DOXIL+Docetaxel
Hide Arm/Group Description:
Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Overall Number of Participants Analyzed 373 378
Median (95% Confidence Interval)
Unit of Measure: Months
20.7
(18.3 to 26.3)
20.4
(19.0 to 23.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, DOXIL+Docetaxel
Comments Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5988
Comments Not adjusted for multiple comparison.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval 95%
0.86 to 1.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)
Hide Description Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).
Time Frame Up to 30 to 42 days after last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population: Included all randomized participants who received at least 1 dose of study medication (DOXIL or docetaxel), and who had at least 1 postbaseline tumor assessment.
Arm/Group Title Docetaxel DOXIL+Docetaxel
Hide Arm/Group Description:
Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Overall Number of Participants Analyzed 364 370
Measure Type: Number
Unit of Measure: Participants
95 129
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, DOXIL+Docetaxel
Comments Null hypothesis - no difference in response rate between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0085
Comments Not adjusted for multiple comparison
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame From first dose of study medication until 30 days after the last dose of study medication.
Adverse Event Reporting Description 751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.
 
Arm/Group Title Docetaxel DOXIL+Docetaxel
Hide Arm/Group Description Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
All-Cause Mortality
Docetaxel DOXIL+Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel DOXIL+Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   59/373 (15.82%)   69/377 (18.30%) 
Blood and lymphatic system disorders     
Neutropenia  1  14/373 (3.75%)  17/377 (4.51%) 
Febrile neutropenia  1  10/373 (2.68%)  10/377 (2.65%) 
Leukopenia  1  1/373 (0.27%)  4/377 (1.06%) 
Anaemia  1  2/373 (0.54%)  2/377 (0.53%) 
Lymphadenopathy  1  0/373 (0.00%)  1/377 (0.27%) 
Cardiac disorders     
cardiac failure  1  2/373 (0.54%)  1/377 (0.27%) 
Atrial fibrillation  1  1/373 (0.27%)  1/377 (0.27%) 
Pericardial effusion  1  2/373 (0.54%)  0/377 (0.00%) 
Cardiac failure congestive  1  1/373 (0.27%)  0/377 (0.00%) 
Cardiomyopathy  1  0/373 (0.00%)  1/377 (0.27%) 
Supraventricular tachycardia  1  0/373 (0.00%)  1/377 (0.27%) 
Tachycardia  1  0/373 (0.00%)  1/377 (0.27%) 
Diabetic ketoacidosis  1  1/373 (0.27%)  0/377 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  3/373 (0.80%)  4/377 (1.06%) 
Diarrhoea  1  2/373 (0.54%)  3/377 (0.80%) 
Nausea  1  3/373 (0.80%)  2/377 (0.53%) 
Stomatitis  1  1/373 (0.27%)  4/377 (1.06%) 
Abdominal pain  1  2/373 (0.54%)  0/377 (0.00%) 
Abdominal mass  1  1/373 (0.27%)  0/377 (0.00%) 
Dysphagia  1  0/373 (0.00%)  1/377 (0.27%) 
Gastric haemorrhage  1  0/373 (0.00%)  1/377 (0.27%) 
Gastrointestinal ulcer  1  0/373 (0.00%)  1/377 (0.27%) 
Ileus  1  1/373 (0.27%)  0/377 (0.00%) 
Intestinal ischaemia  1  0/373 (0.00%)  1/377 (0.27%) 
Peritonitis  1  0/373 (0.00%)  1/377 (0.27%) 
General disorders     
Pyrexia  1  3/373 (0.80%)  6/377 (1.59%) 
Asthenia  1  1/373 (0.27%)  3/377 (0.80%) 
Infusion related reaction  1  0/373 (0.00%)  2/377 (0.53%) 
Death  1  1/373 (0.27%)  0/377 (0.00%) 
Multi-organ failure  1  0/373 (0.00%)  1/377 (0.27%) 
Hepatobiliary disorders     
Biliary colic  1  1/373 (0.27%)  0/377 (0.00%) 
Cholecystitis acute  1  1/373 (0.27%)  0/377 (0.00%) 
Cholelithiasis  1  0/373 (0.00%)  1/377 (0.27%) 
Hyperbilirubinaemia  1  1/373 (0.27%)  0/377 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/373 (0.00%)  1/377 (0.27%) 
Infections and infestations     
Pneumonia  1  0/373 (0.00%)  12/377 (3.18%) 
Neutropenic sepsis  1  4/373 (1.07%)  0/377 (0.00%) 
Cellulitis  1  1/373 (0.27%)  2/377 (0.53%) 
Urinary tract infection  1  1/373 (0.27%)  1/377 (0.27%) 
Appendicitis  1  0/373 (0.00%)  1/377 (0.27%) 
Breast abscess  1  1/373 (0.27%)  0/377 (0.00%) 
Catheter related infection  1  1/373 (0.27%)  0/377 (0.00%) 
Catheter site cellulitis  1  1/373 (0.27%)  0/377 (0.00%) 
Cystitis  1  0/373 (0.00%)  1/377 (0.27%) 
Erysipelas  1  1/373 (0.27%)  0/377 (0.00%) 
Folliculitis  1  0/373 (0.00%)  1/377 (0.27%) 
Groin abscess  1  1/373 (0.27%)  0/377 (0.00%) 
Infection  1  0/373 (0.00%)  1/377 (0.27%) 
Lung infection  1  1/373 (0.27%)  0/377 (0.00%) 
Pulpitis dental  1  1/373 (0.27%)  0/377 (0.00%) 
Pyelonephritis  1  1/373 (0.27%)  0/377 (0.00%) 
Skin infection  1  0/373 (0.00%)  1/377 (0.27%) 
Staphylococcal infection  1  1/373 (0.27%)  0/377 (0.00%) 
Subcutaneous abscess  1  0/373 (0.00%)  1/377 (0.27%) 
Tooth abscess  1  0/373 (0.00%)  1/377 (0.27%) 
Vaginal infection  1  0/373 (0.00%)  1/377 (0.27%) 
Viral infection  1  0/373 (0.00%)  1/377 (0.27%) 
Vulvitis  1  0/373 (0.00%)  1/377 (0.27%) 
Injury, poisoning and procedural complications     
Fall  1  1/373 (0.27%)  1/377 (0.27%) 
Alcohol poisoning  1  0/373 (0.00%)  1/377 (0.27%) 
Humerus fracture  1  1/373 (0.27%)  0/377 (0.00%) 
Upper limb fracture  1  1/373 (0.27%)  0/377 (0.00%) 
Investigations     
Alanine aminotransferease increased  1  1/373 (0.27%)  0/377 (0.00%) 
Aspartate aminotransferase increased  1  1/373 (0.27%)  0/377 (0.00%) 
Blood creatinine increased  1  1/373 (0.27%)  0/377 (0.00%) 
Blood urea increased  1  1/373 (0.27%)  0/377 (0.00%) 
Ejection fraction decreased  1  0/373 (0.00%)  1/377 (0.27%) 
Metabolism and nutrition disorders     
Dehydration  1  3/373 (0.80%)  2/377 (0.53%) 
Hypocalcaemia  1  0/373 (0.00%)  2/377 (0.53%) 
Hypokalaemia  1  1/373 (0.27%)  1/377 (0.27%) 
Hypercalcaemia  1  0/373 (0.00%)  1/377 (0.27%) 
Hyperglycaemia  1  0/373 (0.00%)  1/377 (0.27%) 
Hypomagnesaemia  1  1/373 (0.27%)  0/377 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/373 (0.00%)  1/377 (0.27%) 
Bone pain  1  1/373 (0.27%)  0/377 (0.00%) 
Pathological fracture  1  1/373 (0.27%)  0/377 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/373 (0.27%)  0/377 (0.00%) 
Metastasis  1  0/373 (0.00%)  1/377 (0.27%) 
Neoplasm malignant  1  0/373 (0.00%)  1/377 (0.27%) 
Nervous system disorders     
Convulsion  1  1/373 (0.27%)  1/377 (0.27%) 
Heachache  1  1/373 (0.27%)  1/377 (0.27%) 
Loss of consciousness  1  0/373 (0.00%)  2/377 (0.53%) 
Brain stem syndrome  1  0/373 (0.00%)  1/377 (0.27%) 
Cerebrovascular accident  1  0/373 (0.00%)  1/377 (0.27%) 
Dizziness  1  0/373 (0.00%)  1/377 (0.27%) 
Grand mal convulsion  1  0/373 (0.00%)  1/377 (0.27%) 
Hemiplegia  1  1/373 (0.27%)  0/377 (0.00%) 
Speech disorder  1  0/373 (0.00%)  1/377 (0.27%) 
Syncope  1  0/373 (0.00%)  1/377 (0.27%) 
Psychiatric disorders     
Anxiety  1  1/373 (0.27%)  0/377 (0.00%) 
Mental status changes  1  0/373 (0.00%)  1/377 (0.27%) 
Reproductive system and breast disorders     
Metrorrhagia  1  1/373 (0.27%)  0/377 (0.00%) 
Uterine polyp  1  1/373 (0.27%)  0/377 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  4/373 (1.07%)  0/377 (0.00%) 
Pulmonary embolism  1  2/373 (0.54%)  2/377 (0.53%) 
Dyspnoea  1  2/373 (0.54%)  1/377 (0.27%) 
Acute respiratory failure  1  1/373 (0.27%)  1/377 (0.27%) 
Respiratory arrest  1  0/373 (0.00%)  2/377 (0.53%) 
Respiratory failure  1  0/373 (0.00%)  2/377 (0.53%) 
Asthma  1  0/373 (0.00%)  1/377 (0.27%) 
Asthmatic crisis  1  1/373 (0.27%)  0/377 (0.00%) 
Bronchial haemorrhage  1  0/373 (0.00%)  1/377 (0.27%) 
Bronchospasm  1  0/373 (0.00%)  1/377 (0.27%) 
Hydrothorax  1  1/373 (0.27%)  0/377 (0.00%) 
Hypoxia  1  0/373 (0.00%)  1/377 (0.27%) 
Pneumothorax  1  1/373 (0.27%)  0/377 (0.00%) 
Pulmonary oedema  1  0/373 (0.00%)  1/377 (0.27%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  1  0/373 (0.00%)  7/377 (1.86%) 
Intertrigo  1  0/373 (0.00%)  1/377 (0.27%) 
Surgical and medical procedures     
Surgery  1  0/373 (0.00%)  1/377 (0.27%) 
Uterine dilation and curettage  1  1/373 (0.27%)  0/377 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/373 (0.27%)  0/377 (0.00%) 
Embolism  1  1/373 (0.27%)  0/377 (0.00%) 
Hypertension  1  0/373 (0.00%)  1/377 (0.27%) 
Jugular vein thrombosis  1  1/373 (0.27%)  0/377 (0.00%) 
Phlebitis  1  0/373 (0.00%)  1/377 (0.27%) 
Subclavian vein thrombosis  1  1/373 (0.27%)  0/377 (0.00%) 
Superior vena caval occlusion  1  0/373 (0.00%)  1/377 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel DOXIL+Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   340/373 (91.15%)   359/377 (95.23%) 
Blood and lymphatic system disorders     
Anaemia  1  62/373 (16.62%)  75/377 (19.89%) 
Febrile neutropenia  1  14/373 (3.75%)  19/377 (5.04%) 
Leukopenia  1  99/373 (26.54%)  126/377 (33.42%) 
Neutropenia  1  241/373 (64.61%)  244/377 (64.72%) 
Cardiac disorders     
Tachycardia  1  14/373 (3.75%)  21/377 (5.57%) 
Gastrointestinal disorders     
Constipation  1  18/373 (4.83%)  13/377 (3.45%) 
Diarrhoea  1  42/373 (11.26%)  56/377 (14.85%) 
Mucositis/stomatitis  1  53/373 (14.21%)  195/377 (51.72%) 
Nausea  1  80/373 (21.45%)  105/377 (27.85%) 
Vomiting  1  35/373 (9.38%)  38/377 (10.08%) 
General disorders     
Asthenia  1  72/373 (19.30%)  110/377 (29.18%) 
Fatigue  1  56/373 (15.01%)  78/377 (20.69%) 
Oedema peripheral  1  34/373 (9.12%)  17/377 (4.51%) 
Pyrexia  1  31/373 (8.31%)  59/377 (15.65%) 
Infections and infestations     
Respiratory tract infection  1  12/373 (3.22%)  21/377 (5.57%) 
Investigations     
Alanine aminotransferase increased  1  29/373 (7.77%)  31/377 (8.22%) 
Aspartate aminotransferase increased  1  31/373 (8.31%)  26/377 (6.90%) 
Weight decreased  1  6/373 (1.61%)  18/377 (4.77%) 
Metabolism and nutrition disorders     
Anorexia  1  21/373 (5.63%)  33/377 (8.75%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  25/373 (6.70%)  26/377 (6.90%) 
Bone pain  1  26/373 (6.97%)  12/377 (3.18%) 
Myalgia  1  33/373 (8.85%)  32/377 (8.49%) 
Nervous system disorders     
Dizziness  1  12/373 (3.22%)  18/377 (4.77%) 
Dysgeusia  1  22/373 (5.90%)  10/377 (2.65%) 
Headache  1  21/373 (5.63%)  39/377 (10.34%) 
Peripheral neuropathy  1  68/373 (18.23%)  78/377 (20.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  23/373 (6.17%)  23/377 (6.10%) 
Dyspnoea  1  40/373 (10.72%)  29/377 (7.69%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  169/373 (45.31%)  181/377 (48.01%) 
Erythema  1  6/373 (1.61%)  17/377 (4.51%) 
Nail disorder  1  26/373 (6.97%)  37/377 (9.81%) 
Palmar-plantar erythrodysaesthesia syndrome  1  5/373 (1.34%)  229/377 (60.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission. Expedited reviews will be arranged if needed. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Medical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 908 218 7361
Layout table for additonal information
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00091442     History of Changes
Obsolete Identifiers: NCT00343538
Other Study ID Numbers: CR004120
DOXILBCA3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Submitted: September 8, 2004
First Posted: September 13, 2004
Results First Submitted: December 15, 2009
Results First Posted: October 2, 2012
Last Update Posted: April 21, 2014