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Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT00334893
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : December 10, 2013
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Intervention Drug: eribulin mesylate
Enrollment 74
Recruitment Details Protocol Open to Accrual 4/17/2006 Primary Completion Date 3/13/2012 Recruitment Location at medical clinic
Pre-assignment Details  
Arm/Group Title Platinum Resistant Cohort Platinum Sensitive Cohort
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 37 37
Completed 36 37
Not Completed 1 0
Reason Not Completed
Not Treated             1             0
Arm/Group Title Platinum-Resistant Cohort Platinum-Sensitive Cohort Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 37 37 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  59.5%
26
  70.3%
48
  64.9%
>=65 years
15
  40.5%
11
  29.7%
26
  35.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 74 participants
61
(38 to 80)
60
(45 to 77)
60
(38 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 74 participants
Female
37
 100.0%
37
 100.0%
74
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 37 participants 74 participants
37 37 74
1.Primary Outcome
Title Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
Hide Description 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.
Time Frame up to a total of a year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Platinum-Resistant Disease Platinum-Sensitive Disease
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 36 37
Measure Type: Number
Unit of Measure: participants
Partial Response 2 7
Stable Disease 16 21
2.Secondary Outcome
Title Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
Hide Description Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.
Time Frame From the time of their first treatment with eribulin mesylate
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Platinum-Resistant Cohort Platinum-Sensitive Cohort
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Platinum-Resistant Disease Platinum-Sensitive Disease
Hide Arm/Group Description

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

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

All-Cause Mortality
Platinum-Resistant Disease Platinum-Sensitive Disease
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Platinum-Resistant Disease Platinum-Sensitive Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/36 (47.22%)      16/37 (43.24%)    
Blood and lymphatic system disorders     
Hemoglobin decrease  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Cardiac disorders     
Cardiac ischemia/infarction  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Pain-Cardiac  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Gastrointestinal disorders     
Obstruction-GI-Colon  1  1/36 (2.78%)  1 3/37 (8.11%)  3
Abdominal Pain  1  2/36 (5.56%)  2 1/37 (2.70%)  1
Ileus  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Perforation, GI-Small Bowel NOS  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Vomiting  1  0/36 (0.00%)  0 1/37 (2.70%)  1
General disorders     
Pain-Chest wall  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Infections and infestations     
Infection  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Investigations     
Leukocyte count decrease/white blood cell decrease  1  2/36 (5.56%)  2 3/37 (8.11%)  3
Neutrophil count decrease  1  10/36 (27.78%)  10 12/37 (32.43%)  12
Metabolism and nutrition disorders     
Dehydration  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Phosphate, low (hypophosphatemia)  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Hyponatremia  1  1/36 (2.78%)  1 2/37 (5.41%)  2
Musculoskeletal and connective tissue disorders     
Pain  1  1/36 (2.78%)  1 1/37 (2.70%)  1
Nervous system disorders     
Ataxia  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Neurological disorder  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Renal and urinary disorders     
Urinary tract infection  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Reproductive system and breast disorders     
Death NOS  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Death-Disease progression  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Hypoxia  1  0/36 (0.00%)  0 1/37 (2.70%)  1
Vascular disorders     
Fever  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Hypotension  1  1/36 (2.78%)  1 0/37 (0.00%)  0
Thrombosis/thrombus/embolism  1  4/36 (11.11%)  4 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Platinum-Resistant Disease Platinum-Sensitive Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/36 (44.44%)      19/37 (51.35%)    
Investigations     
Lymphocyte count decrease  1  2/36 (5.56%)  2 2/37 (5.41%)  2
Neutrophil count decrease  1  14/36 (38.89%)  14 18/37 (48.65%)  18
White blood cell decrease  1  11/36 (30.56%)  11 10/37 (27.03%)  10
AST/SGOT increase  1  0/36 (0.00%)  0 2/37 (5.41%)  2
Metabolism and nutrition disorders     
Hypokalemia  1  3/36 (8.33%)  3 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v 3.0
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.
Results Point of Contact
Name/Title: Dr. Martee L. Hensley
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4222
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00334893     History of Changes
Obsolete Identifiers: NCT01645592, NCT01664403
Other Study ID Numbers: NCI-2009-00169
NCI-2009-00169 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-06027
NCI-7431
CDR0000481534
06-027 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
7431 ( Other Identifier: CTEP )
P30CA008748 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
First Submitted: June 7, 2006
First Posted: June 8, 2006
Results First Submitted: October 16, 2013
Results First Posted: December 10, 2013
Last Update Posted: November 29, 2017