Trial Outcomes & Findings for A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy (NCT NCT00267007)
NCT ID: NCT00267007
Last Updated: 2014-06-04
Results Overview
NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2014-06-04
Participant Flow
Participant milestones
| Measure |
PROCRIT 40,000 IU QW
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
PROCRIT 40,000 IU QW
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
PROCRIT 40,000 IU QW
n=19 Participants
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
n=11 Participants
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 14.18 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 12.98 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 13.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.
NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.
Outcome measures
| Measure |
PROCRIT 40,000 IU QW
n=19 Participants
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
n=11 Participants
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
|---|---|---|
|
The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: baseline to Day 128Population: MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.
NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.
Outcome measures
| Measure |
PROCRIT 40,000 IU QW
n=19 Participants
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
n=11 Participants
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
|---|---|---|
|
The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.
|
3 participants
|
0 participants
|
Adverse Events
PROCRIT 40,000 IU QW
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PROCRIT 40,000 IU QW
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal Obstruction
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.3%
1/19
|
9.1%
1/11
|
|
Infections and infestations
Post Procedural Cellulitis
|
5.3%
1/19
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19
|
0.00%
0/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
5.3%
1/19
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.3%
1/19
|
0.00%
0/11
|
|
Vascular disorders
Lymphocele
|
5.3%
1/19
|
0.00%
0/11
|
|
Vascular disorders
Thrombophlebitis Superficial
|
5.3%
1/19
|
0.00%
0/11
|
Other adverse events
| Measure |
PROCRIT 40,000 IU QW
Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
|
Placebo
Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19
|
18.2%
2/11
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.00%
0/19
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
1/19
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Neutropenia
|
36.8%
7/19
|
36.4%
4/11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.6%
6/19
|
18.2%
2/11
|
|
Cardiac disorders
Tachycardia
|
5.3%
1/19
|
0.00%
0/11
|
|
Eye disorders
Diplopia
|
5.3%
1/19
|
0.00%
0/11
|
|
Eye disorders
Dry Eye
|
0.00%
0/19
|
9.1%
1/11
|
|
Eye disorders
Lacrimation Increased
|
5.3%
1/19
|
0.00%
0/11
|
|
Eye disorders
Vision Blurred
|
5.3%
1/19
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.3%
5/19
|
18.2%
2/11
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Anal Discomfort
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Constipation
|
47.4%
9/19
|
45.5%
5/11
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19
|
36.4%
4/11
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19
|
9.1%
1/11
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/19
|
9.1%
1/11
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
84.2%
16/19
|
72.7%
8/11
|
|
Gastrointestinal disorders
Odynophagia
|
10.5%
2/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Stomatitis
|
15.8%
3/19
|
18.2%
2/11
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
42.1%
8/19
|
63.6%
7/11
|
|
General disorders
Asthenia
|
21.1%
4/19
|
18.2%
2/11
|
|
General disorders
Catheter Site Erythema
|
0.00%
0/19
|
9.1%
1/11
|
|
General disorders
Catheter Site Pain
|
0.00%
0/19
|
18.2%
2/11
|
|
General disorders
Fatigue
|
84.2%
16/19
|
72.7%
8/11
|
|
General disorders
Injection Site Reaction
|
5.3%
1/19
|
0.00%
0/11
|
|
General disorders
Mucosal Inflammation
|
10.5%
2/19
|
27.3%
3/11
|
|
General disorders
Non-Cardiac Chest Pain
|
10.5%
2/19
|
0.00%
0/11
|
|
General disorders
Oedema
|
10.5%
2/19
|
0.00%
0/11
|
|
General disorders
Odema Peripheral
|
0.00%
0/19
|
9.1%
1/11
|
|
General disorders
Pain
|
5.3%
1/19
|
0.00%
0/11
|
|
General disorders
Pyrexia
|
26.3%
5/19
|
0.00%
0/11
|
|
Immune system disorders
Drug Hypersensitivity
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Catheter Site Infection
|
5.3%
1/19
|
9.1%
1/11
|
|
Infections and infestations
Fungal Infection
|
10.5%
2/19
|
0.00%
0/11
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19
|
9.1%
1/11
|
|
Infections and infestations
Herpes Simplex
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Post Procedural Infection
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/19
|
9.1%
1/11
|
|
Infections and infestations
Rhinitis
|
15.8%
3/19
|
18.2%
2/11
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.5%
2/19
|
0.00%
0/11
|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
2/19
|
0.00%
0/11
|
|
Infections and infestations
Vaginal Infection
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Viral Infection
|
5.3%
1/19
|
0.00%
0/11
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
5.3%
1/19
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
1/19
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Feeding Tube Complication
|
0.00%
0/19
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
5.3%
1/19
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
5.3%
1/19
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/19
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/19
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.3%
1/19
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
Blood Calcium Decreased
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
Blood Magnesium Decreased
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
Electrocardiogram QT Prolonged
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
Haemoglobin Decreased
|
10.5%
2/19
|
0.00%
0/11
|
|
Investigations
Heart Rate Increased
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/19
|
9.1%
1/11
|
|
Investigations
Urine Output Decreased
|
5.3%
1/19
|
0.00%
0/11
|
|
Investigations
White Blood Cell Count Decreased
|
5.3%
1/19
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Anorexia
|
31.6%
6/19
|
27.3%
3/11
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/19
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.3%
1/19
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.5%
2/19
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
5.3%
1/19
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.1%
4/19
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
21.1%
4/19
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.5%
2/19
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
47.4%
9/19
|
36.4%
4/11
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
1/19
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.3%
1/19
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
5.3%
1/19
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
5.3%
1/19
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Mass
|
0.00%
0/19
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
15.8%
3/19
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/19
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/19
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.3%
1/19
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.8%
7/19
|
36.4%
4/11
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/19
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
15.8%
3/19
|
9.1%
1/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
5.3%
1/19
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19
|
18.2%
2/11
|
|
Nervous system disorders
Dysgeusia
|
21.1%
4/19
|
9.1%
1/11
|
|
Nervous system disorders
Headache
|
21.1%
4/19
|
36.4%
4/11
|
|
Nervous system disorders
Hypoaesthesia
|
21.1%
4/19
|
9.1%
1/11
|
|
Nervous system disorders
Paraesthesia
|
15.8%
3/19
|
27.3%
3/11
|
|
Nervous system disorders
Perripheral Motor Neuropathy
|
31.6%
6/19
|
27.3%
3/11
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
57.9%
11/19
|
81.8%
9/11
|
|
Nervous system disorders
Syncope
|
0.00%
0/19
|
18.2%
2/11
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19
|
9.1%
1/11
|
|
Psychiatric disorders
Confusional State
|
5.3%
1/19
|
0.00%
0/11
|
|
Psychiatric disorders
Depression
|
0.00%
0/19
|
9.1%
1/11
|
|
Psychiatric disorders
Insomia
|
36.8%
7/19
|
9.1%
1/11
|
|
Psychiatric disorders
Mood Altered
|
5.3%
1/19
|
0.00%
0/11
|
|
Psychiatric disorders
Sleep Disorder
|
5.3%
1/19
|
0.00%
0/11
|
|
Renal and urinary disorders
Bladder Spasm
|
5.3%
1/19
|
0.00%
0/11
|
|
Renal and urinary disorders
Dysuria
|
10.5%
2/19
|
0.00%
0/11
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19
|
9.1%
1/11
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/19
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Menopausal Symptons
|
5.3%
1/19
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.3%
1/19
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.3%
1/19
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Vaginal Ulceration
|
0.00%
0/19
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.3%
1/19
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
4/19
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.8%
3/19
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.5%
2/19
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.3%
1/19
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/19
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.3%
1/19
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.6%
10/19
|
45.5%
5/11
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
5.3%
1/19
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.3%
1/19
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
5.3%
1/19
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/19
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
5.3%
1/19
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.8%
3/19
|
18.2%
2/11
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/19
|
9.1%
1/11
|
|
Vascular disorders
Flushing
|
10.5%
2/19
|
9.1%
1/11
|
|
Vascular disorders
Hot Flush
|
10.5%
2/19
|
9.1%
1/11
|
|
Vascular disorders
Hypertension
|
5.3%
1/19
|
0.00%
0/11
|
|
Vascular disorders
Hypotension
|
10.5%
2/19
|
0.00%
0/11
|
|
Vascular disorders
Lymphocele
|
5.3%
1/19
|
0.00%
0/11
|
|
Vascular disorders
Lymphoedema
|
5.3%
1/19
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/19
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dyspepsia
|
26.3%
5/19
|
18.2%
2/11
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19
|
0.00%
0/11
|
Additional Information
Vice President
Centocor Ortho Biotech Services, LLC (COBS)
Phone: 215 325 4464
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60