Trial Outcomes & Findings for Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer (NCT NCT00176488)
NCT ID: NCT00176488
Last Updated: 2017-03-23
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
10 years
Results posted on
2017-03-23
Participant Flow
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) from June 2003 through May 2009.
Participant milestones
| Measure |
Sequential Epirubicin/Vinorelbine
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Beginning on cycle 1, patients will receive G-CSF (Neupogen) at a dose of 5 mcg/kg on Day 4 of treatment for 10 days OR pegfilgrastim (Neulasta) 6 mg on Day 4 of treatment.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Sequential Epirubicin/Vinorelbine
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Beginning on cycle 1, patients will receive G-CSF (Neupogen) at a dose of 5 mcg/kg on Day 4 of treatment for 10 days OR pegfilgrastim (Neulasta) 6 mg on Day 4 of treatment.
|
|---|---|
|
Overall Study
Initiated Cycle 1 Day 1 only
|
1
|
Baseline Characteristics
Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Sequential Epirubicin/Vinorelbine
n=31 Participants
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: Study was closed prematurely and insufficient data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 yearsPopulation: Study was closed prematurely and insufficient data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 yearsPopulation: Study was closed prematurely and insufficient data was collected.
Outcome measures
Outcome data not reported
Adverse Events
Sequential Epirubicin/Vinorelbine
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sequential Epirubicin/Vinorelbine
n=31 participants at risk
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Platelets
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Vascular disorders
Thrombosis/embolism
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Gastrointestinal disorders
Anorexia
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
General disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
38.7%
12/31 • Number of events 14 • 5 years and 6 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Infections and infestations
Infection without neutropenia
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Nervous system disorders
Syncope (fainting)
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (Specify, malignant pleural effusion)
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Other Toxicity - Bilateral Pleural effusion
|
3.2%
1/31 • Number of events 1 • 5 years and 6 months
|
Other adverse events
| Measure |
Sequential Epirubicin/Vinorelbine
n=31 participants at risk
For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.
epirubicin : Epirubicin (100 mg/m2) will be given on Day 1
vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
93.5%
29/31 • Number of events 39 • 5 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
19.4%
6/31 • Number of events 6 • 5 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify,_____)
|
16.1%
5/31 • Number of events 6 • 5 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Gastrointestinal disorders
Nausea
|
83.9%
26/31 • Number of events 48 • 5 years and 6 months
|
|
Gastrointestinal disorders
Constipation
|
48.4%
15/31 • Number of events 33 • 5 years and 6 months
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
48.4%
15/31 • Number of events 24 • 5 years and 6 months
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
41.9%
13/31 • Number of events 17 • 5 years and 6 months
|
|
Gastrointestinal disorders
Vomiting
|
32.3%
10/31 • Number of events 16 • 5 years and 6 months
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
29.0%
9/31 • Number of events 13 • 5 years and 6 months
|
|
Gastrointestinal disorders
Anorexia
|
25.8%
8/31 • Number of events 14 • 5 years and 6 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
22.6%
7/31 • Number of events 9 • 5 years and 6 months
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify,_____)
|
9.7%
3/31 • Number of events 5 • 5 years and 6 months
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
6.5%
2/31 • Number of events 5 • 5 years and 6 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
80.6%
25/31 • Number of events 55 • 5 years and 6 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
22.6%
7/31 • Number of events 7 • 5 years and 6 months
|
|
General disorders
Pain-Other (Specify,___)
|
58.1%
18/31 • Number of events 36 • 5 years and 6 months
|
|
General disorders
Bone pain
|
19.4%
6/31 • Number of events 6 • 5 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
16.1%
5/31 • Number of events 8 • 5 years and 6 months
|
|
General disorders
Headache
|
12.9%
4/31 • Number of events 5 • 5 years and 6 months
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
6.5%
2/31 • Number of events 3 • 5 years and 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
General disorders
Chest pain (non-cardiac and non-pleuritic)
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
74.2%
23/31 • Number of events 68 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Platelets
|
35.5%
11/31 • Number of events 20 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
32.3%
10/31 • Number of events 27 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other (Specify,_____)
|
12.9%
4/31 • Number of events 10 • 5 years and 6 months
|
|
Nervous system disorders
Neuropathy-sensory
|
32.3%
10/31 • Number of events 14 • 5 years and 6 months
|
|
Nervous system disorders
Insomnia
|
22.6%
7/31 • Number of events 7 • 5 years and 6 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
19.4%
6/31 • Number of events 9 • 5 years and 6 months
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
9.7%
3/31 • Number of events 4 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
35.5%
11/31 • Number of events 18 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
6/31 • Number of events 7 • 5 years and 6 months
|
|
Investigations
Hyperglycemia
|
19.4%
6/31 • Number of events 10 • 5 years and 6 months
|
|
Investigations
Hypokalemia
|
19.4%
6/31 • Number of events 8 • 5 years and 6 months
|
|
Investigations
Hyponatremia
|
12.9%
4/31 • Number of events 4 • 5 years and 6 months
|
|
Investigations
Metabolic/Laboratory-Other (Specify,_____)
|
12.9%
4/31 • Number of events 6 • 5 years and 6 months
|
|
Investigations
Hypocalcemia
|
9.7%
3/31 • Number of events 3 • 5 years and 6 months
|
|
General disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
29.0%
9/31 • Number of events 11 • 5 years and 6 months
|
|
Infections and infestations
Infection without neutropenia
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Vascular disorders
Edema
|
29.0%
9/31 • Number of events 11 • 5 years and 6 months
|
|
Cardiac disorders
Hypotension
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
22.6%
7/31 • Number of events 9 • 5 years and 6 months
|
|
Hepatobiliary disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
6.5%
2/31 • Number of events 3 • 5 years and 6 months
|
|
Hepatobiliary disorders
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Endocrine disorders
Hot flashes/flushes
|
12.9%
4/31 • Number of events 4 • 5 years and 6 months
|
|
Eye disorders
Tearing (watery eyes)
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.5%
2/31 • Number of events 2 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage-Other (Specify,_____)
|
6.5%
2/31 • Number of events 3 • 5 years and 6 months
|
Additional Information
Deborah Toppmeyer, MD
Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place