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Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

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ClinicalTrials.gov Identifier: NCT00337077
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : June 23, 2014
Last Update Posted : June 23, 2014
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 Adenocarcinoma of the Prostate
Hormone-refractory Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Intervention Drug: eribulin mesylate
Enrollment 121
Recruitment Details Participants were recruited from ECOG member institutions between November 29, 2006 and August 5, 2009.
Pre-assignment Details  
Arm/Group Title Chemonaive Prior Taxane Two Prior Chemotherapy Regimens
Hide Arm/Group Description Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 43 53 25
Treated 42 52 25
Toxicity Assessed 42 51 25
Eligible and Treated 41 51 24
Patients With Measurable Disease 26 38 13
Completed 0 [1] 0 [1] 0 [1]
Not Completed 43 53 25
Reason Not Completed
Progressive disease             25             37             19
Adverse Event             7             7             1
Death             0             1             0
Withdrawal by Subject             7             2             2
Alternative therapy             1             0             0
Physician Decision             1             4             2
Never started treatment             1             1             0
Ineligible             1             1             1
[1]
No completion of treatment because treatment was given until PD or unacceptable toxicity.
Arm/Group Title Chemonaive Prior Taxane Two Prior Chemotherapy Regimens Total
Hide Arm/Group Description Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 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 41 51 24 116
Hide Baseline Analysis Population Description
Eligible and treated patients are included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants 51 participants 24 participants 116 participants
70
(45 to 86)
67
(45 to 88)
73
(57 to 85)
70
(45 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 51 participants 24 participants 116 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
41
 100.0%
51
 100.0%
24
 100.0%
116
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 51 participants 24 participants 116 participants
41 51 24 116
1.Primary Outcome
Title Proportion of Patients With PSA Response
Hide Description PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.
Time Frame Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients are included in this analysis.
Arm/Group Title Chemonaive Prior Taxane Two Prior Chemotherapy Regimens
Hide Arm/Group Description:
Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 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 41 51 24
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of participants
0.293
(0.182 to 0.442)
0.098
(0.052 to 0.271)
0.042
(0.004 to 0.152)
2.Secondary Outcome
Title Proportion of Patients With Measurable Disease Response
Hide Description Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.
Time Frame Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients with measurable disease at baseline are included in this analysis.
Arm/Group Title Chemonaive Prior Taxane Two Prior Chemotherapy Regimens
Hide Arm/Group Description:
Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 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 26 38 13
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of participants
0.154
(0.054 to 0.318)
0.026
(0.001 to 0.119)
0.077
(0.004 to 0.316)
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
All-Cause Mortality
Eribulin Mesylate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate
Affected / at Risk (%)
Total   81/118 (68.64%) 
Blood and lymphatic system disorders   
Anemia  1  9/118 (7.63%) 
Febrile neutropenia  1  5/118 (4.24%) 
Gastrointestinal disorders   
Muco/stomatitis by exam, oral cavity  1  3/118 (2.54%) 
Muco/stomatitis (symptom) oral cavity  1  1/118 (0.85%) 
Nausea  1  2/118 (1.69%) 
Vomiting  1  1/118 (0.85%) 
General disorders   
Fatigue  1  13/118 (11.02%) 
Extremity-lower (gait/walking)  1  1/118 (0.85%) 
Pain-other  1  1/118 (0.85%) 
Infections and infestations   
Infection w/ gr3-4 neut, sinus  1  1/118 (0.85%) 
Infection Gr0-2 neut, blood  1  1/118 (0.85%) 
Investigations   
Leukocytes decreased  1  49/118 (41.53%) 
Lymphopenia  1  3/118 (2.54%) 
Neutrophils decreased  1  65/118 (55.08%) 
Alanine aminotransferase increased  1  1/118 (0.85%) 
Metabolism and nutrition disorders   
Anorexia  1  5/118 (4.24%) 
Dehydration  1  3/118 (2.54%) 
Hyperglycemia  1  2/118 (1.69%) 
Hyponatremia  1  1/118 (0.85%) 
Musculoskeletal and connective tissue disorders   
Nonneuropathic lower extr muscle weak  1  2/118 (1.69%) 
Muscle, pain  1  1/118 (0.85%) 
Nervous system disorders   
Neuropathy-motor  1  3/118 (2.54%) 
Neuropathy-sensory  1  15/118 (12.71%) 
Syncope  1  1/118 (0.85%) 
Psychiatric disorders   
Confusion  1  1/118 (0.85%) 
Renal and urinary disorders   
Bladder, hemorrhage  1  1/118 (0.85%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/118 (0.85%) 
Vascular disorders   
Hypotension  1  2/118 (1.69%) 
Thrombosis/thrombus/embolism  1  2/118 (1.69%) 
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%
Eribulin Mesylate
Affected / at Risk (%)
Total   111/118 (94.07%) 
Blood and lymphatic system disorders   
Anemia  1  74/118 (62.71%) 
Eye disorders   
Tearing  1  6/118 (5.08%) 
Gastrointestinal disorders   
Constipation  1  33/118 (27.97%) 
Diarrhea w/o prior colostomy  1  19/118 (16.10%) 
Muco/stomatitis by exam, oral cavity  1  16/118 (13.56%) 
Nausea  1  40/118 (33.90%) 
Vomiting  1  9/118 (7.63%) 
General disorders   
Fatigue  1  82/118 (69.49%) 
Edema limb  1  12/118 (10.17%) 
Investigations   
Leukocytes decreased  1  74/118 (62.71%) 
Lymphopenia  1  8/118 (6.78%) 
Neutrophils decreased  1  56/118 (47.46%) 
Platelets decreased  1  11/118 (9.32%) 
Weight loss  1  17/118 (14.41%) 
Alkaline phosphatase increased  1  14/118 (11.86%) 
Alanine aminotransferase increased  1  7/118 (5.93%) 
Aspartate aminotransferase increased  1  11/118 (9.32%) 
Creatinine increased  1  8/118 (6.78%) 
Metabolism and nutrition disorders   
Anorexia  1  38/118 (32.20%) 
Hypoalbuminemia  1  22/118 (18.64%) 
Hypocalcemia  1  7/118 (5.93%) 
Hyperglycemia  1  15/118 (12.71%) 
Musculoskeletal and connective tissue disorders   
Joint, pain  1  6/118 (5.08%) 
Muscle, pain  1  6/118 (5.08%) 
Nervous system disorders   
Taste disturbance  1  11/118 (9.32%) 
Neuropathy-sensory  1  45/118 (38.14%) 
Psychiatric disorders   
Insomnia  1  6/118 (5.08%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  12/118 (10.17%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  46/118 (38.98%) 
Rash/desquamation  1  6/118 (5.08%) 
Vascular disorders   
Hypotension  1  6/118 (5.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 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: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Publications of Results:
Stein MN, Chen Y, Hudes GR, Carducci MA, Tan W, DiPaola RS. ECOG 5805: A phase II study of eribulin mesylate (E7389) in patients (pts) with metastatic castration-resistant prostate cancer (CRPC). J Clin Oncol 28:15s, 2010 (suppl; abstr 4556)
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00337077     History of Changes
Other Study ID Numbers: NCI-2009-00566
NCI-2009-00566 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E5805 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: June 13, 2006
First Posted: June 15, 2006
Results First Submitted: February 14, 2014
Results First Posted: June 23, 2014
Last Update Posted: June 23, 2014