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A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00338286
Collaborator
(none)
2,098
Enrollment
177
Locations
2
Arms
131
Actual Duration (Months)
11.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard supportive care (packed RBC transfusion)
  • Drug: epoetin alfa + packed RBC transfusion
 Phase 3

Detailed Description

Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter, international study to further examine the safety of the study drug used with standard supportive care (i.e., packed RBC transfusions) compared to standard supportive care alone, when used to treat anemia associated with chemotherapy. This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the risk of tumor progression or death. The study treatment will be compared to the control treatment by comparing progression-free survival, i.e., the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death. In addition to their chemotherapy, half of the subjects will be assigned to receive study drug (epoetin alfa) and half of the subjects will be assigned to standard supportive care for anemia. Subjects treated with the study drug will receive standard supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive anemia care, is non-inferior to control (standard supportive care alone), as measured by progression free survival (PFS). Patients treated with the study drug will receive standard supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first. Dose adjustments (dose escalation, dose reduction, dose interruption, and dose resumption) of epoetin alfa will be based on hemoglobin (Hb) and confirm to prescribing information.

Study Design

Study Type:
Interventional
Actual Enrollment :
2098 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Actual Study Start Date :
Mar 2, 2006
Actual Primary Completion Date :
Jul 7, 2014
Actual Study Completion Date :
Jan 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 001

epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.

Drug: epoetin alfa + packed RBC transfusion
40,000 IU SC once a week.
Other: 002

Standard supportive care (packed RBC transfusion) Per doctor prescription

Other: Standard supportive care (packed RBC transfusion)
Per doctor prescription

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival [From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)]

    Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.

Secondary Outcome Measures

  1. Overall Survival [From randomization up to death from any cause (up to 8.4 years)]

    Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock.

  2. Time to Tumor Progression [From date of randomization to the date of the first documented PD (up to 8.4 years)]

    The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).

  3. Overall Response Rate (ORR) [every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)]

    Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.

  4. Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs) [up to 8.4 years]

    Suspected TVEs were identified by investigators and relevant clinical information was collected.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Histologically confirmed (e.g., slide of tissue) breast cancer

  • HER2/NEU positive or negative

  • Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy

  • Received 1st and 2nd line chemotherapy

  • Hemoglobin (Hb) <= 11g/dL at the time of randomization

  • planned to receive at least 2 more cycles of chemotherapy

  • Life expectancy > 6 months

  • Eastern Cooperative Oncology Group score 0 or 1

  • At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year

Exclusion Criteria:

  • Active second cancer

  • no recent history of clinically relevant thrombovascular event

  • Current treatment with anticoagulants

  • Brain metastasis or CNS involvement

  • Anemia secondary to another cause

  • Recent (within prior 1 months) use of an ESA

  • Patient pregnant or breast feeding

  • Progressive disease during adjuvant/neoadjuvant chemotherapy

  • Rapidly progressive or life-threatening metastatic disease

  • Concomitant endocrine therapy

  • Patient in whom the only site of metastasis was local and was successfully treated surgically.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anaheim California United States
2 Gainesville Florida United States
3 Miami Florida United States
4 New Port Richey Florida United States
5 Rockledge Florida United States
6 Hazard Kentucky United States
7 Alexandria Louisiana United States
8 Marrero Louisiana United States
9 Jackson Mississippi United States
10 Lake Success New York United States
11 Staten Island New York United States
12 Philadelphia Pennsylvania United States
13 Corpus Christi Texas United States
14 Houston Texas United States
15 Buenos Aires Argentina
16 Capital Federal Argentina
17 Ciudad Autonoma De Buenos Airess Argentina
18 Cordoba Argentina
19 La Plata Argentina
20 Mendoza Argentina
21 Quilmes Argentina
22 Rosario Argentina
23 Santa Fe Argentina
24 Barretos Brazil
25 Curitiba Brazil
26 Goiânia/Go Brazil
27 Ijuí Brazil
28 Jau Brazil
29 Piracicaba Brazil
30 Porto Alegre Brazil
31 Ribeirão Preto/Sp Brazil
32 Santo Andre Brazil
33 Sao Paulo Brazil
34 São José Do Rio Preto Brazil
35 São Paulol Brazil
36 Plovdiv Bulgaria
37 Rousse Bulgaria
38 Sofia Bulgaria
39 Stara Zagora Bulgaria
40 Varna Bulgaria
41 Arica Chile
42 Santiago Chile
43 Temuco Chile
44 Valdivia Chile
45 Valparaiso Chile
46 Bogota Colombia
47 Floridablanca-Santander Colombia
48 Monteria Colombia
49 Cuenca Ecuador
50 Guayaquil Ecuador
51 Portoviejo Ecuador
52 Quito Ecuador
53 Batumi Georgia
54 Tbilisi Georgia
55 Tblisi Georgia
56 New Territories Hong Kong
57 Ahmedabad India
58 Andra Pradesh India
59 Bangalore N/A India
60 Bangalore India
61 Bhopal India
62 Cochin India
63 Delhi India
64 Hyderabad India
65 Jaipur India
66 Karnad India
67 Kerala India
68 Kolkata India
69 Mangalore India
70 Mumbai India
71 Nashik India
72 New Delhi India
73 Pune India
74 Tamil Nadu Na India
75 Tamil Nadu India
76 Thiruvananthapuram India
77 Uttar Pradesh India
78 Vellore India
79 Bandung Indonesia
80 Jakarta Indonesia
81 Semarang Indonesia
82 Yogyakarta Indonesia
83 Bitola Macedonia, The Former Yugoslav Republic of
84 Skopje Macedonia, The Former Yugoslav Republic of
85 Georgetown Malaysia
86 Kelantan Malaysia
87 Kuala Lumpur Malaysia
88 Nilai Malaysia
89 Tanjung Bunga Malaysia
90 Chihuahua Mexico
91 Guerrero Mexico
92 Leon Mexico
93 Merida Mexico
94 Morelia Mexico
95 Puebla Mexico
96 San Luis Potosi Mexico
97 Sinaloa Mexico
98 Zapopan Mexico
99 Cebu Philippines
100 Davao City Philippines
101 Iloilo City Philippines
102 Manila Philippines
103 Quezon City Philippines
104 Białystok Poland
105 Gdansk Poland
106 Gliwice Poland
107 Katowice N/A Poland
108 Kraków Poland
109 Lodz Poland
110 Olsztyn Poland
111 Poznan Poland
112 Wroclaw Poland
113 Brasov Romania
114 Bucuresti Romania
115 Cluj-Napoca Romania
116 Iasi Romania
117 Onesti Romania
118 Sibiu Romania
119 Suceava Romania
120 Timisoara Romania
121 Arkhangelsk Russian Federation
122 Balashikha Russian Federation
123 Belgorod Russian Federation
124 Chelyabinsk Russian Federation
125 Ekaterinburg Russian Federation
126 Engels Saratov Region Russian Federation
127 Ivanovo Russian Federation
128 Kazan Russian Federation
129 Krasnodar Russian Federation
130 Leningrad Region Russian Federation
131 Lipetsk Russian Federation
132 Magnitogorsk Russian Federation
133 Moscow Russian Federation
134 Novosibirsk Russian Federation
135 Obninsk Russian Federation
136 Orenburg Russian Federation
137 Perm Russian Federation
138 Pyatigorsk Russian Federation
139 Ryazan Russian Federation
140 Smolensk Russian Federation
141 St Petersburg Russian Federation
142 St. Petersburg Russian Federation
143 Tyumen Russian Federation
144 Ufa Russian Federation
145 Voronezh Russian Federation
146 Bloemfontein South Africa
147 Cape Town South Africa
148 Durban South Africa
149 Johannesburg South Africa
150 Klerksdorp South Africa
151 Port Elizabeth N/A South Africa
152 Pretoria South Africa
153 Changhua Taiwan
154 Chiayi Taiwan
155 Hualien Taiwan
156 Kaohsiung Taiwan
157 Taichung Taiwan
158 Tainan Taiwan
159 Taipei 112 Taiwan
160 Taipei Taiwan
161 Tao-Yuan Taiwan
162 Cherkassy Ukraine
163 Chernihiv Ukraine
164 Chernivtsi Ukraine
165 Dnepropetrovsk Ukraine
166 Donetsk Ukraine
167 Ivano-Francovsk Ukraine
168 Kharkiv Ukraine
169 Kiev Ukraine
170 Lviv Ukraine
171 Odessa Ukraine
172 Poltava Ukraine
173 Sumy Ukraine
174 Uzhgorod Ukraine
175 Vinnitsa Ukraine
176 Vinnytsia Ukraine
177 Zaporozhye Ukraine

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC C. Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00338286
Other Study ID Numbers:
  • CR005143
  • EPOANE3010
  • CR005143
  • 2005-001817-17
First Posted:
Jun 20, 2006
Last Update Posted:
Mar 19, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Research & Development, LLC
anemia
metastatic breast cancer
Hemoglobin
progression-free survival (PFS)
erythropoiesis-stimulating agents (ESA)
Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Epoetin Alfa

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Participants in safety data were grouped as treatment actually received (3 were assigned to SOC but received epoetin alfa; 2 were assigned to EPO, but received SOC) so, 1 more to EPO (1051) 1 less in SOC (1045) actually received treatment. Efficacy, safety were analyzed by 1050 (EPO), 1048 (SOC), 1051 (EPO), 1045 (SOC) respectively.
Arm/Group Title Standard Supportive Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
Period Title: Overall Study
STARTED 1048 1050
COMPLETED 815 837
NOT COMPLETED 233 213

Baseline Characteristics

Arm/Group Title Standard Supportive Care (SOC) Epoetin Alfa Total
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week. Total of all reporting groups
Overall Participants 1048 1050 2098
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
51.8
(10.54)
51.9
(10.49)
51.9
(10.51)
Sex: Female, Male (Count of Participants)
Female
1048
100%
1050
100%
2098
100%
Male
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
ARGENTINA
4
0.4%
5
0.5%
9
0.4%
BRAZIL
27
2.6%
16
1.5%
43
2%
BULGARIA
14
1.3%
10
1%
24
1.1%
CHILE
11
1%
13
1.2%
24
1.1%
COLOMBIA
3
0.3%
1
0.1%
4
0.2%
ECUADOR
1
0.1%
1
0.1%
2
0.1%
GEORGIA
241
23%
200
19%
441
21%
HONG KONG
1
0.1%
0
0%
1
0%
INDIA
211
20.1%
237
22.6%
448
21.4%
INDONESIA
4
0.4%
5
0.5%
9
0.4%
MACEDONIA
4
0.4%
5
0.5%
9
0.4%
MALAYSIA
7
0.7%
6
0.6%
13
0.6%
MEXICO
8
0.8%
12
1.1%
20
1%
PHILIPPINES
60
5.7%
54
5.1%
114
5.4%
ROMANIA
0
0%
3
0.3%
3
0.1%
RUSSIA
102
9.7%
129
12.3%
231
11%
TAIWAN
19
1.8%
30
2.9%
49
2.3%
UKRAINE
328
31.3%
318
30.3%
646
30.8%
UNITED STATES OF AMERICA
3
0.3%
5
0.5%
8
0.4%

Outcome Measures

1. Primary Outcome
Title Progression Free Survival
Description Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
Time Frame From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)

Outcome Measure Data

Analysis Population Description
The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.
Arm/Group Title Standard of Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion. Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
Measure Participants 1048 1050
Median (95% Confidence Interval) [Months]
7.4
7.4
2. Secondary Outcome
Title Overall Survival
Description Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock.
Time Frame From randomization up to death from any cause (up to 8.4 years)

Outcome Measure Data

Analysis Population Description
The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.
Arm/Group Title Standard of Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion. Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
Measure Participants 1048 1050
Median (95% Confidence Interval) [Months]
18.0
17.8
3. Secondary Outcome
Title Time to Tumor Progression
Description The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).
Time Frame From date of randomization to the date of the first documented PD (up to 8.4 years)

Outcome Measure Data

Analysis Population Description
The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.
Arm/Group Title Standard of Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion. Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
Measure Participants 1048 1050
Median (95% Confidence Interval) [Months]
7.5
7.5
4. Secondary Outcome
Title Overall Response Rate (ORR)
Description Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.
Time Frame every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)

Outcome Measure Data

Analysis Population Description
The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.
Arm/Group Title Standard of Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion. Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
Measure Participants 1048 1050
Complete response (CR)
3
0.3%
3
0.3%
Partial response (PR)
48
4.6%
47
4.5%
Stable disease (SD)
30
2.9%
32
3%
Progressive disease (PD)
13
1.2%
12
1.1%
Not evaluable (NE)
1
0.1%
2
0.2%
Not available (NA)
5
0.5%
5
0.5%
5. Secondary Outcome
Title Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)
Description Suspected TVEs were identified by investigators and relevant clinical information was collected.
Time Frame up to 8.4 years

Outcome Measure Data

Analysis Population Description
The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.
Arm/Group Title Standard of Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion. Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
Measure Participants 1048 1050
Number [Percentage of participants]
3.72
0.4%
4.86
0.5%

Adverse Events

Time Frame From randomization up to 8.4 years
Adverse Event Reporting Description The Safety analysis set included included all randomized participants for whom safety assessment data were available. Participants in the safety population were grouped according to the treatment actually received.
Arm/Group Title Standard Supportive Care (SOC) Epoetin Alfa
Arm/Group Description Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
All Cause Mortality
Standard Supportive Care (SOC) Epoetin Alfa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Standard Supportive Care (SOC) Epoetin Alfa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 229/1045 (21.9%) 251/1051 (23.9%)
Blood and lymphatic system disorders
Agranulocytosis 0/1045 (0%) 1/1051 (0.1%)
Anaemia 15/1045 (1.4%) 10/1051 (1%)
Bone Marrow Failure 0/1045 (0%) 1/1051 (0.1%)
Febrile Neutropenia 29/1045 (2.8%) 40/1051 (3.8%)
Leukopenia 9/1045 (0.9%) 10/1051 (1%)
Neutropenia 55/1045 (5.3%) 52/1051 (4.9%)
Neutrophilia 1/1045 (0.1%) 0/1051 (0%)
Pancytopenia 3/1045 (0.3%) 7/1051 (0.7%)
Thrombocytopenia 12/1045 (1.1%) 18/1051 (1.7%)
Cardiac disorders
Acute Myocardial Infarction 2/1045 (0.2%) 2/1051 (0.2%)
Arrhythmia 0/1045 (0%) 1/1051 (0.1%)
Arteriosclerosis Coronary Artery 0/1045 (0%) 1/1051 (0.1%)
Atrial Fibrillation 3/1045 (0.3%) 0/1051 (0%)
Cardiac Arrest 1/1045 (0.1%) 0/1051 (0%)
Cardiac Disorder 0/1045 (0%) 1/1051 (0.1%)
Cardiac Failure 5/1045 (0.5%) 2/1051 (0.2%)
Cardiac Failure Acute 2/1045 (0.2%) 3/1051 (0.3%)
Cardiac Failure Chronic 1/1045 (0.1%) 0/1051 (0%)
Cardiac Failure Congestive 0/1045 (0%) 1/1051 (0.1%)
Cardiac Tamponade 0/1045 (0%) 1/1051 (0.1%)
Cardio-Respiratory Arrest 5/1045 (0.5%) 3/1051 (0.3%)
Cardiopulmonary Failure 1/1045 (0.1%) 2/1051 (0.2%)
Cardiovascular Insufficiency 1/1045 (0.1%) 0/1051 (0%)
Cyanosis 0/1045 (0%) 1/1051 (0.1%)
Left Ventricular Dysfunction 1/1045 (0.1%) 0/1051 (0%)
Left Ventricular Failure 0/1045 (0%) 1/1051 (0.1%)
Myocarditis 1/1045 (0.1%) 0/1051 (0%)
Palpitations 1/1045 (0.1%) 0/1051 (0%)
Pericardial Effusion 0/1045 (0%) 1/1051 (0.1%)
Sinus Tachycardia 1/1045 (0.1%) 0/1051 (0%)
Tachycardia 1/1045 (0.1%) 0/1051 (0%)
Ear and labyrinth disorders
Vertigo 1/1045 (0.1%) 3/1051 (0.3%)
Eye disorders
Amaurosis 1/1045 (0.1%) 0/1051 (0%)
Retinal Artery Thrombosis 1/1045 (0.1%) 0/1051 (0%)
Vision Blurred 0/1045 (0%) 1/1051 (0.1%)
Gastrointestinal disorders
Abdominal Discomfort 0/1045 (0%) 1/1051 (0.1%)
Abdominal Distension 0/1045 (0%) 2/1051 (0.2%)
Abdominal Pain 4/1045 (0.4%) 4/1051 (0.4%)
Abdominal Pain Upper 0/1045 (0%) 1/1051 (0.1%)
Ascites 2/1045 (0.2%) 1/1051 (0.1%)
Constipation 1/1045 (0.1%) 3/1051 (0.3%)
Diarrhoea 17/1045 (1.6%) 13/1051 (1.2%)
Dyspepsia 0/1045 (0%) 1/1051 (0.1%)
Dysphagia 1/1045 (0.1%) 1/1051 (0.1%)
Enteritis 0/1045 (0%) 1/1051 (0.1%)
Gastrointestinal Haemorrhage 0/1045 (0%) 2/1051 (0.2%)
Gastrointestinal Toxicity 0/1045 (0%) 2/1051 (0.2%)
Haematochezia 1/1045 (0.1%) 0/1051 (0%)
Haemorrhoids 1/1045 (0.1%) 0/1051 (0%)
Jejunal Perforation 0/1045 (0%) 1/1051 (0.1%)
Lower Gastrointestinal Haemorrhage 1/1045 (0.1%) 0/1051 (0%)
Mouth Ulceration 1/1045 (0.1%) 0/1051 (0%)
Nausea 1/1045 (0.1%) 2/1051 (0.2%)
Oral Pain 0/1045 (0%) 1/1051 (0.1%)
Pancreatitis Acute 0/1045 (0%) 1/1051 (0.1%)
Peptic Ulcer 1/1045 (0.1%) 0/1051 (0%)
Proctitis 1/1045 (0.1%) 0/1051 (0%)
Stomatitis 4/1045 (0.4%) 2/1051 (0.2%)
Vomiting 11/1045 (1.1%) 9/1051 (0.9%)
General disorders
Abasia 0/1045 (0%) 1/1051 (0.1%)
Asthenia 9/1045 (0.9%) 8/1051 (0.8%)
Chest Discomfort 0/1045 (0%) 1/1051 (0.1%)
Chest Pain 2/1045 (0.2%) 1/1051 (0.1%)
Death 1/1045 (0.1%) 7/1051 (0.7%)
Disease Progression 0/1045 (0%) 1/1051 (0.1%)
Facial Pain 1/1045 (0.1%) 0/1051 (0%)
Fatigue 4/1045 (0.4%) 4/1051 (0.4%)
Generalised Oedema 0/1045 (0%) 1/1051 (0.1%)
Malaise 2/1045 (0.2%) 0/1051 (0%)
Mucosal Inflammation 5/1045 (0.5%) 2/1051 (0.2%)
Multiple Organ Dysfunction Syndrome 6/1045 (0.6%) 2/1051 (0.2%)
Non-Cardiac Chest Pain 1/1045 (0.1%) 1/1051 (0.1%)
Oedema Peripheral 2/1045 (0.2%) 1/1051 (0.1%)
Pain 1/1045 (0.1%) 2/1051 (0.2%)
Peripheral Swelling 1/1045 (0.1%) 0/1051 (0%)
Pyrexia 9/1045 (0.9%) 10/1051 (1%)
Sudden Death 6/1045 (0.6%) 3/1051 (0.3%)
Hepatobiliary disorders
Acute Hepatic Failure 0/1045 (0%) 1/1051 (0.1%)
Cholecystitis Acute 0/1045 (0%) 2/1051 (0.2%)
Cholecystitis Chronic 0/1045 (0%) 1/1051 (0.1%)
Hepatic Failure 2/1045 (0.2%) 1/1051 (0.1%)
Hepatic Lesion 1/1045 (0.1%) 0/1051 (0%)
Hepatitis Toxic 0/1045 (0%) 1/1051 (0.1%)
Hepatomegaly 0/1045 (0%) 1/1051 (0.1%)
Hepatorenal Syndrome 1/1045 (0.1%) 0/1051 (0%)
Hyperbilirubinaemia 0/1045 (0%) 1/1051 (0.1%)
Jaundice 1/1045 (0.1%) 3/1051 (0.3%)
Jaundice Hepatocellular 1/1045 (0.1%) 0/1051 (0%)
Infections and infestations
Abdominal Infection 0/1045 (0%) 1/1051 (0.1%)
Amoebiasis 1/1045 (0.1%) 0/1051 (0%)
Appendicitis 0/1045 (0%) 1/1051 (0.1%)
Biliary Sepsis 0/1045 (0%) 1/1051 (0.1%)
Breast Abscess 1/1045 (0.1%) 0/1051 (0%)
Breast Cellulitis 1/1045 (0.1%) 2/1051 (0.2%)
Bronchitis 0/1045 (0%) 1/1051 (0.1%)
Bronchopulmonary Aspergillosis 0/1045 (0%) 1/1051 (0.1%)
Candida Infection 1/1045 (0.1%) 0/1051 (0%)
Cellulitis 6/1045 (0.6%) 2/1051 (0.2%)
Device Related Infection 1/1045 (0.1%) 1/1051 (0.1%)
Fungal Infection 1/1045 (0.1%) 0/1051 (0%)
Gastroenteritis 3/1045 (0.3%) 0/1051 (0%)
Groin Abscess 0/1045 (0%) 1/1051 (0.1%)
Hepatitis Viral 0/1045 (0%) 2/1051 (0.2%)
Herpes Zoster 1/1045 (0.1%) 1/1051 (0.1%)
Infectious Pleural Effusion 0/1045 (0%) 1/1051 (0.1%)
Injection Site Abscess 2/1045 (0.2%) 0/1051 (0%)
Lower Respiratory Tract Infection 1/1045 (0.1%) 1/1051 (0.1%)
Lung Infection 2/1045 (0.2%) 3/1051 (0.3%)
Mastitis 0/1045 (0%) 1/1051 (0.1%)
Neutropenic Infection 0/1045 (0%) 1/1051 (0.1%)
Neutropenic Sepsis 1/1045 (0.1%) 0/1051 (0%)
Oropharyngeal Candidiasis 1/1045 (0.1%) 0/1051 (0%)
Peritonitis 0/1045 (0%) 2/1051 (0.2%)
Plasmodium Falciparum Infection 0/1045 (0%) 1/1051 (0.1%)
Pneumonia 11/1045 (1.1%) 12/1051 (1.1%)
Pulmonary Tuberculosis 0/1045 (0%) 2/1051 (0.2%)
Respiratory Tract Infection 2/1045 (0.2%) 2/1051 (0.2%)
Respiratory Tract Infection Viral 1/1045 (0.1%) 0/1051 (0%)
Sepsis 7/1045 (0.7%) 7/1051 (0.7%)
Septic Shock 2/1045 (0.2%) 1/1051 (0.1%)
Tuberculosis Gastrointestinal 1/1045 (0.1%) 0/1051 (0%)
Upper Respiratory Tract Infection 2/1045 (0.2%) 0/1051 (0%)
Urinary Tract Infection 2/1045 (0.2%) 2/1051 (0.2%)
Viral Infection 1/1045 (0.1%) 0/1051 (0%)
Injury, poisoning and procedural complications
Fall 0/1045 (0%) 2/1051 (0.2%)
Femoral Neck Fracture 1/1045 (0.1%) 1/1051 (0.1%)
Femur Fracture 3/1045 (0.3%) 0/1051 (0%)
Hip Fracture 1/1045 (0.1%) 0/1051 (0%)
Post Procedural Haemorrhage 1/1045 (0.1%) 0/1051 (0%)
Radius Fracture 1/1045 (0.1%) 1/1051 (0.1%)
Rib Fracture 0/1045 (0%) 1/1051 (0.1%)
Road Traffic Accident 1/1045 (0.1%) 0/1051 (0%)
Investigations
Alanine Aminotransferase Increased 0/1045 (0%) 1/1051 (0.1%)
Aspartate Aminotransferase Increased 0/1045 (0%) 1/1051 (0.1%)
Biopsy Liver 0/1045 (0%) 1/1051 (0.1%)
Metabolism and nutrition disorders
Decreased Appetite 2/1045 (0.2%) 3/1051 (0.3%)
Dehydration 4/1045 (0.4%) 1/1051 (0.1%)
Diabetes Mellitus 1/1045 (0.1%) 0/1051 (0%)
Diabetes Mellitus Inadequate Control 0/1045 (0%) 1/1051 (0.1%)
Electrolyte Imbalance 0/1045 (0%) 1/1051 (0.1%)
Failure to Thrive 1/1045 (0.1%) 0/1051 (0%)
Hyperglycaemia 1/1045 (0.1%) 0/1051 (0%)
Hypoalbuminaemia 0/1045 (0%) 1/1051 (0.1%)
Hypocalcaemia 2/1045 (0.2%) 1/1051 (0.1%)
Hypokalaemia 1/1045 (0.1%) 2/1051 (0.2%)
Hyponatraemia 2/1045 (0.2%) 4/1051 (0.4%)
Hypoproteinaemia 0/1045 (0%) 1/1051 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia 1/1045 (0.1%) 0/1051 (0%)
Back Pain 1/1045 (0.1%) 1/1051 (0.1%)
Muscular Weakness 1/1045 (0.1%) 0/1051 (0%)
Musculoskeletal Pain 0/1045 (0%) 1/1051 (0.1%)
Myalgia 1/1045 (0.1%) 1/1051 (0.1%)
Neck Pain 1/1045 (0.1%) 0/1051 (0%)
Pain in Extremity 1/1045 (0.1%) 0/1051 (0%)
Pain in Jaw 1/1045 (0.1%) 0/1051 (0%)
Pathological Fracture 0/1045 (0%) 1/1051 (0.1%)
Soft Tissue Necrosis 1/1045 (0.1%) 0/1051 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer 0/1045 (0%) 3/1051 (0.3%)
Cervix Carcinoma 0/1045 (0%) 1/1051 (0.1%)
Lymphangiosis Carcinomatosa 1/1045 (0.1%) 0/1051 (0%)
Malignant Pleural Effusion 0/1045 (0%) 2/1051 (0.2%)
Metastases to Central Nervous System 2/1045 (0.2%) 10/1051 (1%)
Metastases to Liver 0/1045 (0%) 1/1051 (0.1%)
Metastases to Meninges 1/1045 (0.1%) 2/1051 (0.2%)
Metastases to the Respiratory System 1/1045 (0.1%) 0/1051 (0%)
Oncologic Complication 0/1045 (0%) 1/1051 (0.1%)
Rectal Adenocarcinoma 1/1045 (0.1%) 0/1051 (0%)
Sarcoma 0/1045 (0%) 1/1051 (0.1%)
Tumour Haemorrhage 2/1045 (0.2%) 1/1051 (0.1%)
Uterine Leiomyoma 1/1045 (0.1%) 0/1051 (0%)
Nervous system disorders
Altered State of Consciousness 0/1045 (0%) 1/1051 (0.1%)
Brain Oedema 0/1045 (0%) 1/1051 (0.1%)
Central Nervous System Haemorrhage 1/1045 (0.1%) 0/1051 (0%)
Cerebral Haemorrhage 1/1045 (0.1%) 0/1051 (0%)
Cerebral Infarction 1/1045 (0.1%) 1/1051 (0.1%)
Cerebrovascular Accident 0/1045 (0%) 1/1051 (0.1%)
Depressed Level of Consciousness 2/1045 (0.2%) 3/1051 (0.3%)
Diabetic Hyperglycaemic Coma 0/1045 (0%) 1/1051 (0.1%)
Dizziness 2/1045 (0.2%) 1/1051 (0.1%)
Dysarthria 1/1045 (0.1%) 2/1051 (0.2%)
Encephalopathy 1/1045 (0.1%) 0/1051 (0%)
Haemorrhage Intracranial 0/1045 (0%) 1/1051 (0.1%)
Haemorrhagic Cerebral Infarction 0/1045 (0%) 1/1051 (0.1%)
Headache 6/1045 (0.6%) 4/1051 (0.4%)
Hemiparesis 1/1045 (0.1%) 1/1051 (0.1%)
Hemiplegia 2/1045 (0.2%) 0/1051 (0%)
Hepatic Encephalopathy 1/1045 (0.1%) 0/1051 (0%)
Hydrocephalus 1/1045 (0.1%) 1/1051 (0.1%)
Hypoaesthesia 1/1045 (0.1%) 0/1051 (0%)
Hypoxic-Ischaemic Encephalopathy 0/1045 (0%) 1/1051 (0.1%)
Iiird Nerve Paralysis 1/1045 (0.1%) 0/1051 (0%)
Incoherent 0/1045 (0%) 1/1051 (0.1%)
Intracranial Pressure Increased 1/1045 (0.1%) 0/1051 (0%)
Ischaemic Stroke 0/1045 (0%) 1/1051 (0.1%)
Loss of Consciousness 1/1045 (0.1%) 1/1051 (0.1%)
Monoparesis 0/1045 (0%) 1/1051 (0.1%)
Neuropathy Peripheral 2/1045 (0.2%) 3/1051 (0.3%)
Paraesthesia 1/1045 (0.1%) 0/1051 (0%)
Peripheral Motor Neuropathy 1/1045 (0.1%) 2/1051 (0.2%)
Peripheral Sensorimotor Neuropathy 1/1045 (0.1%) 0/1051 (0%)
Peripheral Sensory Neuropathy 0/1045 (0%) 2/1051 (0.2%)
Seizure 6/1045 (0.6%) 4/1051 (0.4%)
Somnolence 0/1045 (0%) 2/1051 (0.2%)
Vertebral Artery Thrombosis 0/1045 (0%) 1/1051 (0.1%)
Pregnancy, puerperium and perinatal conditions
Pregnancy 1/1045 (0.1%) 0/1051 (0%)
Product Issues
Device Breakage 1/1045 (0.1%) 0/1051 (0%)
Psychiatric disorders
Abnormal Behaviour 0/1045 (0%) 1/1051 (0.1%)
Confusional State 1/1045 (0.1%) 0/1051 (0%)
Depressed Mood 0/1045 (0%) 1/1051 (0.1%)
Mental Status Changes 2/1045 (0.2%) 0/1051 (0%)
Schizophrenia 0/1045 (0%) 1/1051 (0.1%)
Renal and urinary disorders
Acute Kidney Injury 0/1045 (0%) 1/1051 (0.1%)
Renal Failure 2/1045 (0.2%) 0/1051 (0%)
Urinary Retention 1/1045 (0.1%) 0/1051 (0%)
Reproductive system and breast disorders
Breast Mass 1/1045 (0.1%) 0/1051 (0%)
Ovarian Cyst Torsion 0/1045 (0%) 1/1051 (0.1%)
Pelvic Pain 2/1045 (0.2%) 0/1051 (0%)
Uterine Polyp 0/1045 (0%) 1/1051 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema 2/1045 (0.2%) 0/1051 (0%)
Acute Respiratory Distress Syndrome 1/1045 (0.1%) 0/1051 (0%)
Acute Respiratory Failure 2/1045 (0.2%) 3/1051 (0.3%)
Alveolitis Allergic 0/1045 (0%) 1/1051 (0.1%)
Aspiration 1/1045 (0.1%) 0/1051 (0%)
Asthma 2/1045 (0.2%) 0/1051 (0%)
Bronchospasm 1/1045 (0.1%) 1/1051 (0.1%)
Cough 3/1045 (0.3%) 0/1051 (0%)
Dyspnoea 16/1045 (1.5%) 19/1051 (1.8%)
Haemoptysis 1/1045 (0.1%) 0/1051 (0%)
Haemothorax 1/1045 (0.1%) 0/1051 (0%)
Hydrothorax 1/1045 (0.1%) 0/1051 (0%)
Hypoxia 0/1045 (0%) 1/1051 (0.1%)
Oropharyngeal Pain 0/1045 (0%) 1/1051 (0.1%)
Orthopnoea 0/1045 (0%) 1/1051 (0.1%)
Pleural Effusion 14/1045 (1.3%) 13/1051 (1.2%)
Pneumonia Aspiration 1/1045 (0.1%) 0/1051 (0%)
Pneumothorax 3/1045 (0.3%) 2/1051 (0.2%)
Pulmonary Artery Thrombosis 0/1045 (0%) 1/1051 (0.1%)
Pulmonary Embolism 6/1045 (0.6%) 5/1051 (0.5%)
Pulmonary Haemorrhage 0/1045 (0%) 1/1051 (0.1%)
Pulmonary Infarction 0/1045 (0%) 1/1051 (0.1%)
Pulmonary Thrombosis 0/1045 (0%) 1/1051 (0.1%)
Respiratory Acidosis 1/1045 (0.1%) 0/1051 (0%)
Respiratory Arrest 1/1045 (0.1%) 0/1051 (0%)
Respiratory Distress 1/1045 (0.1%) 1/1051 (0.1%)
Respiratory Failure 4/1045 (0.4%) 2/1051 (0.2%)
Restrictive Pulmonary Disease 0/1045 (0%) 1/1051 (0.1%)
Skin and subcutaneous tissue disorders
Blister 0/1045 (0%) 1/1051 (0.1%)
Dermatitis Exfoliative 0/1045 (0%) 1/1051 (0.1%)
Intertrigo 0/1045 (0%) 1/1051 (0.1%)
Palmar-Plantar Erythrodysaesthesia Syndrome 1/1045 (0.1%) 0/1051 (0%)
Petechiae 1/1045 (0.1%) 0/1051 (0%)
Rash 0/1045 (0%) 2/1051 (0.2%)
Skin Lesion 0/1045 (0%) 1/1051 (0.1%)
Stevens-Johnson Syndrome 1/1045 (0.1%) 0/1051 (0%)
Vascular disorders
Deep Vein Thrombosis 0/1045 (0%) 2/1051 (0.2%)
Haemorrhage 1/1045 (0.1%) 0/1051 (0%)
Hypertension 1/1045 (0.1%) 2/1051 (0.2%)
Hypotension 3/1045 (0.3%) 5/1051 (0.5%)
Hypovolaemic Shock 1/1045 (0.1%) 0/1051 (0%)
Phlebitis 1/1045 (0.1%) 0/1051 (0%)
Shock 1/1045 (0.1%) 0/1051 (0%)
Superior Vena Cava Syndrome 0/1045 (0%) 1/1051 (0.1%)
Vena Cava Thrombosis 1/1045 (0.1%) 0/1051 (0%)
Venous Thrombosis 1/1045 (0.1%) 0/1051 (0%)
Other (Not Including Serious) Adverse Events
Standard Supportive Care (SOC) Epoetin Alfa
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 883/1045 (84.5%) 898/1051 (85.4%)
Blood and lymphatic system disorders
Anaemia 153/1045 (14.6%) 98/1051 (9.3%)
Leukopenia 279/1045 (26.7%) 270/1051 (25.7%)
Neutropenia 550/1045 (52.6%) 530/1051 (50.4%)
Thrombocytopenia 97/1045 (9.3%) 95/1051 (9%)
Gastrointestinal disorders
Constipation 40/1045 (3.8%) 53/1051 (5%)
Diarrhoea 189/1045 (18.1%) 180/1051 (17.1%)
Dry Mouth 46/1045 (4.4%) 57/1051 (5.4%)
Nausea 232/1045 (22.2%) 257/1051 (24.5%)
Stomatitis 79/1045 (7.6%) 71/1051 (6.8%)
Vomiting 113/1045 (10.8%) 99/1051 (9.4%)
General disorders
Asthenia 139/1045 (13.3%) 131/1051 (12.5%)
Fatigue 215/1045 (20.6%) 201/1051 (19.1%)
Oedema Peripheral 81/1045 (7.8%) 73/1051 (6.9%)
Pyrexia 115/1045 (11%) 121/1051 (11.5%)
Investigations
Alanine Aminotransferase Increased 67/1045 (6.4%) 71/1051 (6.8%)
Aspartate Aminotransferase Increased 66/1045 (6.3%) 77/1051 (7.3%)
Metabolism and nutrition disorders
Decreased Appetite 190/1045 (18.2%) 182/1051 (17.3%)
Musculoskeletal and connective tissue disorders
Arthralgia 81/1045 (7.8%) 56/1051 (5.3%)
Back Pain 54/1045 (5.2%) 55/1051 (5.2%)
Pain in Extremity 59/1045 (5.6%) 66/1051 (6.3%)
Nervous system disorders
Dysgeusia 56/1045 (5.4%) 74/1051 (7%)
Headache 74/1045 (7.1%) 89/1051 (8.5%)
Neuropathy Peripheral 74/1045 (7.1%) 83/1051 (7.9%)
Peripheral Sensory Neuropathy 111/1045 (10.6%) 97/1051 (9.2%)
Respiratory, thoracic and mediastinal disorders
Cough 95/1045 (9.1%) 122/1051 (11.6%)
Dyspnoea 74/1045 (7.1%) 77/1051 (7.3%)
Skin and subcutaneous tissue disorders
Alopecia 326/1045 (31.2%) 314/1051 (29.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.

Results Point of Contact

Name/Title Director, Clinical Research
Organization Janssen Research and Development
Phone
Email ClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00338286
Other Study ID Numbers:
  • CR005143
  • EPOANE3010
  • CR005143
  • 2005-001817-17
First Posted:
Jun 20, 2006
Last Update Posted:
Mar 19, 2018
Last Verified:
Feb 1, 2018