Trial Outcomes & Findings for Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer (NCT NCT00334893)
NCT ID: NCT00334893
Last Updated: 2017-11-29
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
up to a total of a year
Results posted on
2017-11-29
Participant Flow
Protocol Open to Accrual 4/17/2006 Primary Completion Date 3/13/2012 Recruitment Location at medical clinic
Participant milestones
| Measure |
Platinum Resistant Cohort
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
Platinum Sensitive Cohort
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Platinum Resistant Cohort
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
Platinum Sensitive Cohort
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
|---|---|---|
|
Overall Study
Not Treated
|
1
|
0
|
Baseline Characteristics
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Platinum-Resistant Cohort
n=37 Participants
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
Platinum-Sensitive Cohort
n=37 Participants
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=74 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
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to a total of a yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Platinum-Resistant Disease
n=36 Participants
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
Platinum-Sensitive Disease
n=37 Participants
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
|---|---|---|
|
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Partial Response
|
2 participants
|
7 participants
|
|
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Stable Disease
|
16 participants
|
21 participants
|
SECONDARY outcome
Timeframe: From the time of their first treatment with eribulin mesylatePopulation: Data were not collected
Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.
Outcome measures
Outcome data not reported
Adverse Events
Platinum-Resistant Disease
Serious events: 17 serious events
Other events: 16 other events
Deaths: 0 deaths
Platinum-Sensitive Disease
Serious events: 16 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Platinum-Resistant Disease
n=36 participants at risk
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
Platinum-Sensitive Disease
n=37 participants at risk
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
|---|---|---|
|
Reproductive system and breast disorders
Death-Disease progression
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Vascular disorders
Fever
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Blood and lymphatic system disorders
Hemoglobin decrease
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Renal and urinary disorders
Urinary tract infection
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Infection
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Investigations
Leukocyte count decrease/white blood cell decrease
|
5.6%
2/36 • Number of events 2
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Neutrophil count decrease
|
27.8%
10/36 • Number of events 10
|
32.4%
12/37 • Number of events 12
|
|
Gastrointestinal disorders
Obstruction-GI-Colon
|
2.8%
1/36 • Number of events 1
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
2/36 • Number of events 2
|
2.7%
1/37 • Number of events 1
|
|
Cardiac disorders
Pain-Cardiac
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
General disorders
Pain-Chest wall
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.8%
1/36 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
11.1%
4/36 • Number of events 4
|
0.00%
0/37
|
|
Nervous system disorders
Ataxia
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Neurological disorder
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Perforation, GI-Small Bowel NOS
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
|
Reproductive system and breast disorders
Death NOS
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
Other adverse events
| Measure |
Platinum-Resistant Disease
n=36 participants at risk
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
Platinum-Sensitive Disease
n=37 participants at risk
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
eribulin mesylate : Given IV
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
3/36 • Number of events 3
|
0.00%
0/37
|
|
Investigations
Lymphocyte count decrease
|
5.6%
2/36 • Number of events 2
|
5.4%
2/37 • Number of events 2
|
|
Investigations
Neutrophil count decrease
|
38.9%
14/36 • Number of events 14
|
48.6%
18/37 • Number of events 18
|
|
Investigations
White blood cell decrease
|
30.6%
11/36 • Number of events 11
|
27.0%
10/37 • Number of events 10
|
|
Investigations
AST/SGOT increase
|
0.00%
0/36
|
5.4%
2/37 • Number of events 2
|
Additional Information
Dr. Martee L. Hensley
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60