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Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00080301
Recruitment Status : Completed
First Posted : March 30, 2004
Results First Posted : August 17, 2009
Last Update Posted : March 10, 2016
Sponsor:
Information provided by:
R-Pharm

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Metastases
Interventions Drug: Ixabepilone + Capecitabine
Drug: Capecitabine
Enrollment 752
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days Capecitabine 1250 mg/m2 BID x 14 days
Period Title: Overall Study
Started 375 377
Never Treated 5 10
Still on Treatment 0 1
Completed 370 [1] 366 [1]
Not Completed 5 11
Reason Not Completed
Randomized but Never Treated             5             10
Still on Treatment as of CSR date             0             1
[1]
Participants who are off treatment
Arm/Group Title Ixabepilone + Capecitabine Capecitabine Total
Hide Arm/Group Description Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days Capecitabine 1250 mg/m2 BID x 14 days Total of all reporting groups
Overall Number of Baseline Participants 375 377 752
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
<65 years 336 322 658
>= 65 years 39 54 93
<50 years 135 145 280
>= 50 years 240 231 471
Unknown 0 1 1
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 375 participants 377 participants 752 participants
53.0
(25.0 to 76.0)
52.0
(25.0 to 79.0)
53.0
(25.0 to 79.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Female
375
 100.0%
376
  99.7%
751
  99.9%
Male
0
   0.0%
1
   0.3%
1
   0.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
American Indian or Alaska Native 1 0 1
Asian 83 87 170
Black or African American 11 11 22
White 257 247 504
Other 23 32 55
Disease Sites  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Ascites 14 14 28
Bone 168 162 330
Breast 61 63 124
Chest Wall 53 53 106
Effusion 57 55 112
Lymph Node 250 249 499
Other 20 18 38
Peritoneum 7 14 21
Pleura 29 35 64
Skin/Soft Tissue 60 62 122
Visceral, Liver 245 228 473
Visceral, Lung 180 174 354
Visceral, Other 34 28 62
Disease Sites at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Liver ± Lung ± Skin/Soft Tissue ± Bone 245 228 473
Lung ± Skin/Soft Tissue ± Bone 71 87 158
Skin/Soft Tissue ± Bone 49 52 101
Bone 0 3 3
Other 6 5 11
Karnofsky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 375 participants 377 participants 752 participants
100 108 105 213
90 145 132 277
80 86 102 188
70 33 34 67
<70 0 1 1
Not reported 3 3 6
[1]
Measure Description: Karnofsky Performance Scale Index measures a patient's functional impairment: 100-80=Able to carry on normal activity and work, no special care; 70-50=Unable to work; able to live at home and care for most personal needs with assistance; 40-0=Unable to care for self; institutional or hospital care needed. Score reported in multiples of 10.
Menopausal Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Premenopausal 54 51 105
Perimenopausal 19 23 42
Postmenopausal 288 289 577
Not reported 14 14 28
Number of Disease Sites  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
1 disease site 39 34 73
2 disease sites 85 98 183
3 disease sites 110 121 231
4 disease sites 79 69 148
≥5 disease sites 58 53 111
Presence of All Lesions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Subjects with at least 1 lesion 371 375 746
Subjects with no lesions 4 2 6
Visceral Disease in Liver and/or Lung  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 375 participants 377 participants 752 participants
Yes 316 315 631
No 55 60 115
Missing 4 2 6
1.Primary Outcome
Title Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
Hide Description PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn’t progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Time Frame based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
PFS was analyzed on all randomized patients on an intention to treat basis.
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 375 377
Median (95% Confidence Interval)
Unit of Measure: Months
5.85
(5.45 to 6.97)
4.17
(3.81 to 4.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixabepilone + Capecitabine, Capecitabine
Comments Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O’Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0003
Comments Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse > 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)
Method Log Rank
Comments 95.17% confidence interval is adjusted for the interim analysis.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval 95.17%
0.64 to 0.88
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR) Per IRRC
Hide Description Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
Time Frame based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of ORR was conducted on all randomized patients on an intent to treat basis.
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 375 377
Mean (95% Confidence Interval)
Unit of Measure: percent
34.7
(29.9 to 39.7)
14.3
(10.9 to 18.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixabepilone + Capecitabine, Capecitabine
Comments The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.15
Confidence Interval 95%
2.20 to 4.50
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Duration of Response Per IRRC
Hide Description Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
Time Frame based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Results for duration of response apply to only those subjects with a response (defined as complete or partial response).
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 130 54
Median (95% Confidence Interval)
Unit of Measure: months
6.4
(5.6 to 7.1)
5.6
(4.2 to 7.5)
4.Secondary Outcome
Title Time to Response Per IRRC
Hide Description Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
Time Frame based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
Results for time to response apply to only those subjects with a response (defined as complete or partial response)
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 130 54
Median (Full Range)
Unit of Measure: weeks
11.7
(4.4 to 61.4)
12.0
(4.3 to 41.9)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
Time Frame from date of randomization until death
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival was analyzed on all randomized patients on an intent to treat basis.
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 375 377
Median (95% Confidence Interval)
Unit of Measure: Months
12.9
(11.5 to 14.2)
11.1
(10.0 to 12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixabepilone + Capecitabine, Capecitabine
Comments Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1936
Comments Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse > 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).
Method Log Rank
Comments Test was conducted at the α=0.05 level and no adjustments were performed.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval 95.17%
0.77 to 1.05
Estimation Comments Confidence Interval adjusted for interim analysis.
6.Secondary Outcome
Title Treatment-related Safety Summary
Hide Description Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
Time Frame safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 369 368
Measure Type: Number
Unit of Measure: Participants
Deaths on-study or within 30 days of last dose 33 40
Treatment-related Serious Adverse Events (SAEs) 91 31
Treatment-related Adverse Events (AEs) 357 330
Treatment-related AEs leading to Discontinuation 137 25
7.Secondary Outcome
Title Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Hide Description Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Time Frame Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on all randomized participants on an intent to treat basis.(Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)
Arm/Group Title Ixabepilone + Capecitabine Capecitabine
Hide Arm/Group Description:
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine 1250 mg/m2 BID x 14 days
Overall Number of Participants Analyzed 375 377
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 3 (n=282; n=273)
-0.4
(-0.97 to 0.20)
0.3
(-0.28 to 0.84)
Week 6 (n=227; n=214)
-0.2
(-0.90 to 0.48)
1.1
(0.30 to 1.83)
Week 9 (n=194; n=184)
-0.6
(-1.31 to 0.19)
1.8
(0.97 to 2.58)
Week 12 (n=173; n=158)
-1.3
(-2.19 to -0.42)
1.4
(0.55 to 2.18)
Week 15 (n=148; n=145)
-0.7
(-1.65 to 0.27)
1.7
(0.73 to 2.72)
Week 18 (n=122; n=121)
-1.0
(-2.18 to 0.13)
1.7
(0.76 to 2.63)
Week 21 (n=116; n=101)
-0.7
(-1.63 to 0.28)
1.1
(0.01 to 2.21)
Week 24 (n=95; n=82)
-0.8
(-1.89 to 0.38)
2.3
(1.13 to 3.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixabepilone + Capecitabine, Capecitabine
Comments There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0002
Comments [Not Specified]
Method Wei-Lachin
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine Ixabepilone + Capecitabine
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Capecitabine Ixabepilone + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine Ixabepilone + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   127/368 (34.51%)   151/369 (40.92%) 
Blood and lymphatic system disorders     
ANAEMIA  1  3/368 (0.82%)  11/369 (2.98%) 
LEUKOPENIA  1  0/368 (0.00%)  6/369 (1.63%) 
NEUTROPENIA  1  0/368 (0.00%)  18/369 (4.88%) 
COAGULOPATHY  1  3/368 (0.82%)  0/369 (0.00%) 
LYMPHADENOPATHY  1  0/368 (0.00%)  1/369 (0.27%) 
THROMBOCYTOPENIA  1  2/368 (0.54%)  7/369 (1.90%) 
BONE MARROW FAILURE  1  0/368 (0.00%)  1/369 (0.27%) 
FEBRILE NEUTROPENIA  1  4/368 (1.09%)  15/369 (4.07%) 
DISSEMINATED INTRAVASCULAR COAGULATION  1  0/368 (0.00%)  1/369 (0.27%) 
Cardiac disorders     
ATRIAL FLUTTER  1  0/368 (0.00%)  1/369 (0.27%) 
CARDIAC ARREST  1  0/368 (0.00%)  1/369 (0.27%) 
CARDIOMYOPATHY  1  0/368 (0.00%)  1/369 (0.27%) 
ANGINA PECTORIS  1  0/368 (0.00%)  1/369 (0.27%) 
CARDIAC FAILURE  1  0/368 (0.00%)  1/369 (0.27%) 
ATRIAL FIBRILLATION  1  0/368 (0.00%)  1/369 (0.27%) 
MYOCARDIAL ISCHAEMIA  1  1/368 (0.27%)  1/369 (0.27%) 
PERICARDIAL EFFUSION  1  1/368 (0.27%)  0/369 (0.00%) 
MYOCARDIAL INFARCTION  1  0/368 (0.00%)  1/369 (0.27%) 
CARDIOPULMONARY FAILURE  1  0/368 (0.00%)  1/369 (0.27%) 
VENTRICULAR DYSFUNCTION  1  0/368 (0.00%)  3/369 (0.81%) 
CARDIO-RESPIRATORY ARREST  1  2/368 (0.54%)  1/369 (0.27%) 
ACUTE MYOCARDIAL INFARCTION  1  0/368 (0.00%)  1/369 (0.27%) 
ARRHYTHMIA SUPRAVENTRICULAR  1  0/368 (0.00%)  1/369 (0.27%) 
Gastrointestinal disorders     
ILEUS  1  1/368 (0.27%)  3/369 (0.81%) 
NAUSEA  1  5/368 (1.36%)  8/369 (2.17%) 
ASCITES  1  2/368 (0.54%)  1/369 (0.27%) 
COLITIS  1  1/368 (0.27%)  0/369 (0.00%) 
MELAENA  1  1/368 (0.27%)  0/369 (0.00%) 
VOMITING  1  8/368 (2.17%)  12/369 (3.25%) 
CHEILITIS  1  1/368 (0.27%)  0/369 (0.00%) 
DIARRHOEA  1  15/368 (4.08%)  14/369 (3.79%) 
DYSPEPSIA  1  0/368 (0.00%)  1/369 (0.27%) 
ENTERITIS  1  2/368 (0.54%)  0/369 (0.00%) 
GASTRITIS  1  1/368 (0.27%)  1/369 (0.27%) 
STOMATITIS  1  1/368 (0.27%)  3/369 (0.81%) 
CONSTIPATION  1  2/368 (0.54%)  1/369 (0.27%) 
HAEMATEMESIS  1  1/368 (0.27%)  0/369 (0.00%) 
OESOPHAGITIS  1  0/368 (0.00%)  1/369 (0.27%) 
PANCREATITIS  1  0/368 (0.00%)  1/369 (0.27%) 
PEPTIC ULCER  1  1/368 (0.27%)  0/369 (0.00%) 
ABDOMINAL PAIN  1  4/368 (1.09%)  4/369 (1.08%) 
ABDOMINAL PAIN UPPER  1  1/368 (0.27%)  0/369 (0.00%) 
EROSIVE OESOPHAGITIS  1  1/368 (0.27%)  0/369 (0.00%) 
GASTROINTESTINAL ULCER  1  0/368 (0.00%)  1/369 (0.27%) 
GASTROINTESTINAL HAEMORRHAGE  1  2/368 (0.54%)  0/369 (0.00%) 
GASTROINTESTINAL OBSTRUCTION  1  1/368 (0.27%)  0/369 (0.00%) 
LARGE INTESTINAL OBSTRUCTION  1  0/368 (0.00%)  1/369 (0.27%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  0/368 (0.00%)  2/369 (0.54%) 
General disorders     
PAIN  1  0/368 (0.00%)  2/369 (0.54%) 
DEATH  1  1/368 (0.27%)  2/369 (0.54%) 
CHILLS  1  0/368 (0.00%)  1/369 (0.27%) 
FATIGUE  1  1/368 (0.27%)  3/369 (0.81%) 
PYREXIA  1  3/368 (0.82%)  9/369 (2.44%) 
ASTHENIA  1  2/368 (0.54%)  3/369 (0.81%) 
CHEST PAIN  1  1/368 (0.27%)  1/369 (0.27%) 
SUDDEN DEATH  1  0/368 (0.00%)  1/369 (0.27%) 
GENERALISED OEDEMA  1  1/368 (0.27%)  0/369 (0.00%) 
MUCOSAL INFLAMMATION  1  3/368 (0.82%)  4/369 (1.08%) 
PERFORMANCE STATUS DECREASED  1  0/368 (0.00%)  1/369 (0.27%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/368 (0.27%)  1/369 (0.27%) 
Hepatobiliary disorders     
HEPATIC FAILURE  1  4/368 (1.09%)  1/369 (0.27%) 
ACUTE HEPATIC FAILURE  1  0/368 (0.00%)  1/369 (0.27%) 
HEPATOCELLULAR DAMAGE  1  1/368 (0.27%)  0/369 (0.00%) 
Immune system disorders     
HYPERSENSITIVITY  1  0/368 (0.00%)  2/369 (0.54%) 
TYPE IV HYPERSENSITIVITY REACTION  1  0/368 (0.00%)  1/369 (0.27%) 
Infections and infestations     
SEPSIS  1  0/368 (0.00%)  5/369 (1.36%) 
MYIASIS  1  1/368 (0.27%)  0/369 (0.00%) 
CYSTITIS  1  0/368 (0.00%)  1/369 (0.27%) 
INFECTION  1  2/368 (0.54%)  1/369 (0.27%) 
PNEUMONIA  1  3/368 (0.82%)  17/369 (4.61%) 
CELLULITIS  1  0/368 (0.00%)  3/369 (0.81%) 
ERYSIPELAS  1  1/368 (0.27%)  1/369 (0.27%) 
LARYNGITIS  1  0/368 (0.00%)  1/369 (0.27%) 
PARONYCHIA  1  0/368 (0.00%)  1/369 (0.27%) 
BACTERAEMIA  1  1/368 (0.27%)  0/369 (0.00%) 
SEPTIC SHOCK  1  1/368 (0.27%)  1/369 (0.27%) 
HERPES ZOSTER  1  2/368 (0.54%)  2/369 (0.54%) 
GASTROENTERITIS  1  1/368 (0.27%)  2/369 (0.54%) 
LOBAR PNEUMONIA  1  0/368 (0.00%)  1/369 (0.27%) 
PERITONEAL INFECTION  1  1/368 (0.27%)  0/369 (0.00%) 
NEUTROPENIC INFECTION  1  0/368 (0.00%)  1/369 (0.27%) 
ENTEROCOLITIS INFECTIOUS  1  0/368 (0.00%)  1/369 (0.27%) 
PNEUMONIA STAPHYLOCOCCAL  1  0/368 (0.00%)  1/369 (0.27%) 
GASTROINTESTINAL INFECTION  1  1/368 (0.27%)  0/369 (0.00%) 
RESPIRATORY TRACT INFECTION  1  1/368 (0.27%)  2/369 (0.54%) 
GENITOURINARY TRACT INFECTION  1  1/368 (0.27%)  0/369 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  0/368 (0.00%)  1/369 (0.27%) 
Injury, poisoning and procedural complications     
FALL  1  0/368 (0.00%)  2/369 (0.54%) 
OVERDOSE  1  1/368 (0.27%)  0/369 (0.00%) 
HIP FRACTURE  1  1/368 (0.27%)  0/369 (0.00%) 
ANKLE FRACTURE  1  1/368 (0.27%)  1/369 (0.27%) 
FEMUR FRACTURE  1  1/368 (0.27%)  0/369 (0.00%) 
VASCULAR ACCESS COMPLICATION  1  0/368 (0.00%)  1/369 (0.27%) 
POST LUMBAR PUNCTURE SYNDROME  1  1/368 (0.27%)  0/369 (0.00%) 
Investigations     
HAEMOGLOBIN DECREASED  1  1/368 (0.27%)  1/369 (0.27%) 
GRIP STRENGTH DECREASED  1  0/368 (0.00%)  1/369 (0.27%) 
PLATELET COUNT DECREASED  1  2/368 (0.54%)  2/369 (0.54%) 
NEUTROPHIL COUNT DECREASED  1  0/368 (0.00%)  1/369 (0.27%) 
GRANULOCYTE COUNT DECREASED  1  0/368 (0.00%)  1/369 (0.27%) 
WHITE BLOOD CELL COUNT DECREASED  1  0/368 (0.00%)  1/369 (0.27%) 
Metabolism and nutrition disorders     
ANOREXIA  1  2/368 (0.54%)  2/369 (0.54%) 
DEHYDRATION  1  3/368 (0.82%)  8/369 (2.17%) 
HYPOKALAEMIA  1  0/368 (0.00%)  3/369 (0.81%) 
HYPOVOLAEMIA  1  0/368 (0.00%)  1/369 (0.27%) 
HYPOCALCAEMIA  1  0/368 (0.00%)  1/369 (0.27%) 
HYPOGLYCAEMIA  1  1/368 (0.27%)  0/369 (0.00%) 
HYPONATRAEMIA  1  0/368 (0.00%)  3/369 (0.81%) 
HYPERCALCAEMIA  1  1/368 (0.27%)  1/369 (0.27%) 
HYPERGLYCAEMIA  1  0/368 (0.00%)  2/369 (0.54%) 
METABOLIC ACIDOSIS  1  0/368 (0.00%)  1/369 (0.27%) 
DIABETIC KETOACIDOSIS  1  1/368 (0.27%)  0/369 (0.00%) 
Musculoskeletal and connective tissue disorders     
MYALGIA  1  0/368 (0.00%)  3/369 (0.81%) 
TRISMUS  1  0/368 (0.00%)  1/369 (0.27%) 
BACK PAIN  1  1/368 (0.27%)  1/369 (0.27%) 
BONE PAIN  1  3/368 (0.82%)  1/369 (0.27%) 
ARTHRALGIA  1  1/368 (0.27%)  1/369 (0.27%) 
MUSCLE SPASMS  1  0/368 (0.00%)  1/369 (0.27%) 
PAIN IN EXTREMITY  1  1/368 (0.27%)  2/369 (0.54%) 
MUSCULOSKELETAL PAIN  1  1/368 (0.27%)  0/369 (0.00%) 
PATHOLOGICAL FRACTURE  1  1/368 (0.27%)  1/369 (0.27%) 
MUSCULOSKELETAL CHEST PAIN  1  0/368 (0.00%)  1/369 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CANCER PAIN  1  1/368 (0.27%)  0/369 (0.00%) 
BREAST CANCER  1  1/368 (0.27%)  0/369 (0.00%) 
METASTATIC PAIN  1  1/368 (0.27%)  0/369 (0.00%) 
CERVIX CARCINOMA  1  1/368 (0.27%)  0/369 (0.00%) 
INFECTED NEOPLASM  1  0/368 (0.00%)  1/369 (0.27%) 
MALIGNANT ASCITES  1  1/368 (0.27%)  1/369 (0.27%) 
METASTASES TO BONE  1  0/368 (0.00%)  1/369 (0.27%) 
NEOPLASM MALIGNANT  1  1/368 (0.27%)  0/369 (0.00%) 
METASTASES TO LIVER  1  2/368 (0.54%)  0/369 (0.00%) 
METASTASES TO MENINGES  1  0/368 (0.00%)  1/369 (0.27%) 
MALIGNANT PLEURAL EFFUSION  1  2/368 (0.54%)  2/369 (0.54%) 
MALIGNANT NEOPLASM PROGRESSION  1  36/368 (9.78%)  19/369 (5.15%) 
PERICARDIAL EFFUSION MALIGNANT  1  4/368 (1.09%)  0/369 (0.00%) 
METASTASES TO CENTRAL NERVOUS SYSTEM  1  8/368 (2.17%)  7/369 (1.90%) 
RENAL CELL CARCINOMA STAGE UNSPECIFIED  1  1/368 (0.27%)  0/369 (0.00%) 
Nervous system disorders     
APHASIA  1  1/368 (0.27%)  0/369 (0.00%) 
SYNCOPE  1  1/368 (0.27%)  1/369 (0.27%) 
HEADACHE  1  1/368 (0.27%)  1/369 (0.27%) 
LETHARGY  1  0/368 (0.00%)  1/369 (0.27%) 
DIZZINESS  1  0/368 (0.00%)  4/369 (1.08%) 
NEURALGIA  1  0/368 (0.00%)  1/369 (0.27%) 
CONVULSION  1  2/368 (0.54%)  0/369 (0.00%) 
SOMNOLENCE  1  0/368 (0.00%)  1/369 (0.27%) 
PARAESTHESIA  1  0/368 (0.00%)  1/369 (0.27%) 
HYPOAESTHESIA  1  0/368 (0.00%)  1/369 (0.27%) 
MENTAL IMPAIRMENT  1  0/368 (0.00%)  1/369 (0.27%) 
CEREBRAL ISCHAEMIA  1  0/368 (0.00%)  1/369 (0.27%) 
COGNITIVE DISORDER  1  1/368 (0.27%)  1/369 (0.27%) 
CEREBRAL HAEMORRHAGE  1  0/368 (0.00%)  1/369 (0.27%) 
COORDINATION ABNORMAL  1  1/368 (0.27%)  1/369 (0.27%) 
INTERCOSTAL NEURALGIA  1  1/368 (0.27%)  0/369 (0.00%) 
LOSS OF CONSCIOUSNESS  1  0/368 (0.00%)  1/369 (0.27%) 
NEUROPATHY PERIPHERAL  1  0/368 (0.00%)  2/369 (0.54%) 
PARESIS CRANIAL NERVE  1  1/368 (0.27%)  0/369 (0.00%) 
SPINAL CORD COMPRESSION  1  1/368 (0.27%)  1/369 (0.27%) 
MARCHIAFAVA-BIGNAMI DISEASE  1  1/368 (0.27%)  0/369 (0.00%) 
PERIPHERAL MOTOR NEUROPATHY  1  1/368 (0.27%)  3/369 (0.81%) 
PERIPHERAL SENSORY NEUROPATHY  1  0/368 (0.00%)  5/369 (1.36%) 
Psychiatric disorders     
ANXIETY  1  1/368 (0.27%)  0/369 (0.00%) 
DEPRESSION  1  0/368 (0.00%)  1/369 (0.27%) 
DISORIENTATION  1  1/368 (0.27%)  0/369 (0.00%) 
CONFUSIONAL STATE  1  2/368 (0.54%)  2/369 (0.54%) 
Renal and urinary disorders     
HAEMATURIA  1  1/368 (0.27%)  0/369 (0.00%) 
RENAL FAILURE  1  1/368 (0.27%)  1/369 (0.27%) 
RENAL IMPAIRMENT  1  1/368 (0.27%)  0/369 (0.00%) 
URINARY RETENTION  1  1/368 (0.27%)  0/369 (0.00%) 
RENAL FAILURE ACUTE  1  1/368 (0.27%)  0/369 (0.00%) 
Reproductive system and breast disorders     
UTERINE HAEMORRHAGE  1  1/368 (0.27%)  0/369 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
HYPOXIA  1  0/368 (0.00%)  1/369 (0.27%) 
DYSPNOEA  1  7/368 (1.90%)  14/369 (3.79%) 
DYSPHONIA  1  0/368 (0.00%)  1/369 (0.27%) 
HYDROTHORAX  1  1/368 (0.27%)  0/369 (0.00%) 
PNEUMONITIS  1  4/368 (1.09%)  0/369 (0.00%) 
PNEUMOTHORAX  1  1/368 (0.27%)  2/369 (0.54%) 
LUNG DISORDER  1  0/368 (0.00%)  1/369 (0.27%) 
PLEURITIC PAIN  1  1/368 (0.27%)  0/369 (0.00%) 
PLEURAL EFFUSION  1  9/368 (2.45%)  6/369 (1.63%) 
HYDROPNEUMOTHORAX  1  1/368 (0.27%)  1/369 (0.27%) 
PULMONARY EMBOLISM  1  1/368 (0.27%)  2/369 (0.54%) 
RESPIRATORY FAILURE  1  1/368 (0.27%)  4/369 (1.08%) 
PULMONARY HAEMORRHAGE  1  1/368 (0.27%)  0/369 (0.00%) 
ACUTE PULMONARY OEDEMA  1  0/368 (0.00%)  1/369 (0.27%) 
PHARYNGOLARYNGEAL PAIN  1  0/368 (0.00%)  1/369 (0.27%) 
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/368 (0.27%)  0/369 (0.00%) 
Skin and subcutaneous tissue disorders     
RASH  1  0/368 (0.00%)  1/369 (0.27%) 
SKIN ULCER  1  1/368 (0.27%)  0/369 (0.00%) 
ERYTHEMA MULTIFORME  1  0/368 (0.00%)  1/369 (0.27%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  1/368 (0.27%)  5/369 (1.36%) 
Vascular disorders     
THROMBOSIS  1  0/368 (0.00%)  3/369 (0.81%) 
VASCULITIS  1  0/368 (0.00%)  1/369 (0.27%) 
HYPOTENSION  1  2/368 (0.54%)  3/369 (0.81%) 
LYMPHOEDEMA  1  1/368 (0.27%)  0/369 (0.00%) 
HYPERTENSION  1  0/368 (0.00%)  1/369 (0.27%) 
THROMBOPHLEBITIS  1  1/368 (0.27%)  0/369 (0.00%) 
HYPOVOLAEMIC SHOCK  1  0/368 (0.00%)  1/369 (0.27%) 
POOR VENOUS ACCESS  1  1/368 (0.27%)  2/369 (0.54%) 
DEEP VEIN THROMBOSIS  1  4/368 (1.09%)  0/369 (0.00%) 
JUGULAR VEIN THROMBOSIS  1  1/368 (0.27%)  0/369 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine Ixabepilone + Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   350/368 (95.11%)   360/369 (97.56%) 
Blood and lymphatic system disorders     
ANAEMIA  1  10/368 (2.72%)  19/369 (5.15%) 
LEUKOPENIA  1  1/368 (0.27%)  22/369 (5.96%) 
NEUTROPENIA  1  9/368 (2.45%)  51/369 (13.82%) 
Eye disorders     
LACRIMATION INCREASED  1  21/368 (5.71%)  21/369 (5.69%) 
Gastrointestinal disorders     
NAUSEA  1  164/368 (44.57%)  209/369 (56.64%) 
VOMITING  1  106/368 (28.80%)  158/369 (42.82%) 
DIARRHOEA  1  147/368 (39.95%)  179/369 (48.51%) 
DYSPEPSIA  1  35/368 (9.51%)  34/369 (9.21%) 
STOMATITIS  1  39/368 (10.60%)  61/369 (16.53%) 
CONSTIPATION  1  57/368 (15.49%)  120/369 (32.52%) 
ABDOMINAL PAIN  1  51/368 (13.86%)  68/369 (18.43%) 
ABDOMINAL DISTENSION  1  12/368 (3.26%)  19/369 (5.15%) 
ABDOMINAL PAIN UPPER  1  31/368 (8.42%)  45/369 (12.20%) 
General disorders     
PAIN  1  8/368 (2.17%)  27/369 (7.32%) 
FATIGUE  1  97/368 (26.36%)  160/369 (43.36%) 
PYREXIA  1  47/368 (12.77%)  56/369 (15.18%) 
ASTHENIA  1  57/368 (15.49%)  101/369 (27.37%) 
CHEST PAIN  1  19/368 (5.16%)  22/369 (5.96%) 
OEDEMA PERIPHERAL  1  46/368 (12.50%)  51/369 (13.82%) 
MUCOSAL INFLAMMATION  1  39/368 (10.60%)  59/369 (15.99%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  16/368 (4.35%)  23/369 (6.23%) 
Investigations     
WEIGHT DECREASED  1  43/368 (11.68%)  88/369 (23.85%) 
HAEMOGLOBIN DECREASED  1  4/368 (1.09%)  21/369 (5.69%) 
NEUTROPHIL COUNT DECREASED  1  6/368 (1.63%)  27/369 (7.32%) 
WHITE BLOOD CELL COUNT DECREASED  1  3/368 (0.82%)  23/369 (6.23%) 
Metabolism and nutrition disorders     
ANOREXIA  1  69/368 (18.75%)  127/369 (34.42%) 
DECREASED APPETITE  1  8/368 (2.17%)  21/369 (5.69%) 
Musculoskeletal and connective tissue disorders     
MYALGIA  1  24/368 (6.52%)  130/369 (35.23%) 
BACK PAIN  1  53/368 (14.40%)  46/369 (12.47%) 
BONE PAIN  1  19/368 (5.16%)  26/369 (7.05%) 
ARTHRALGIA  1  25/368 (6.79%)  87/369 (23.58%) 
PAIN IN EXTREMITY  1  30/368 (8.15%)  70/369 (18.97%) 
MUSCULOSKELETAL PAIN  1  16/368 (4.35%)  41/369 (11.11%) 
MUSCULOSKELETAL CHEST PAIN  1  20/368 (5.43%)  20/369 (5.42%) 
Nervous system disorders     
HEADACHE  1  41/368 (11.14%)  63/369 (17.07%) 
DIZZINESS  1  36/368 (9.78%)  48/369 (13.01%) 
DYSGEUSIA  1  14/368 (3.80%)  42/369 (11.38%) 
PARAESTHESIA  1  22/368 (5.98%)  71/369 (19.24%) 
HYPOAESTHESIA  1  9/368 (2.45%)  29/369 (7.86%) 
NEUROPATHY PERIPHERAL  1  5/368 (1.36%)  29/369 (7.86%) 
PERIPHERAL MOTOR NEUROPATHY  1  8/368 (2.17%)  68/369 (18.43%) 
PERIPHERAL SENSORY NEUROPATHY  1  30/368 (8.15%)  139/369 (37.67%) 
Psychiatric disorders     
INSOMNIA  1  25/368 (6.79%)  61/369 (16.53%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  59/368 (16.03%)  73/369 (19.78%) 
DYSPNOEA  1  67/368 (18.21%)  61/369 (16.53%) 
Skin and subcutaneous tissue disorders     
RASH  1  27/368 (7.34%)  45/369 (12.20%) 
ALOPECIA  1  16/368 (4.35%)  121/369 (32.79%) 
DRY SKIN  1  25/368 (6.79%)  23/369 (6.23%) 
ERYTHEMA  1  17/368 (4.62%)  25/369 (6.78%) 
PRURITUS  1  15/368 (4.08%)  21/369 (5.69%) 
NAIL DISORDER  1  36/368 (9.78%)  76/369 (20.60%) 
SKIN HYPERPIGMENTATION  1  53/368 (14.40%)  41/369 (11.11%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  228/368 (61.96%)  235/369 (63.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial’s primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00080301     History of Changes
Other Study ID Numbers: CA163-046
First Submitted: March 26, 2004
First Posted: March 30, 2004
Results First Submitted: May 1, 2009
Results First Posted: August 17, 2009
Last Update Posted: March 10, 2016