Trial Outcomes & Findings for Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00337077)
NCT ID: NCT00337077
Last Updated: 2014-06-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
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
Results posted on
2014-06-23
Participant Flow
Participants were recruited from ECOG member institutions between November 29, 2006 and August 5, 2009.
Participant milestones
| Measure |
Chemonaive
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.
|
Prior Taxane
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.
|
Two Prior Chemotherapy Regimens
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 Study
STARTED
|
43
|
53
|
25
|
|
Overall Study
Treated
|
42
|
52
|
25
|
|
Overall Study
Toxicity Assessed
|
42
|
51
|
25
|
|
Overall Study
Eligible and Treated
|
41
|
51
|
24
|
|
Overall Study
Patients With Measurable Disease
|
26
|
38
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
53
|
25
|
Reasons for withdrawal
| Measure |
Chemonaive
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.
|
Prior Taxane
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.
|
Two Prior Chemotherapy Regimens
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 Study
Progressive disease
|
25
|
37
|
19
|
|
Overall Study
Adverse Event
|
7
|
7
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
2
|
|
Overall Study
Alternative therapy
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
4
|
2
|
|
Overall Study
Never started treatment
|
1
|
1
|
0
|
|
Overall Study
Ineligible
|
1
|
1
|
1
|
Baseline Characteristics
Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Chemonaive
n=41 Participants
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.
|
Prior Taxane
n=51 Participants
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.
|
Two Prior Chemotherapy Regimens
n=24 Participants
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
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
67 years
n=107 Participants
|
73 years
n=206 Participants
|
70 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
116 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
51 participants
n=107 Participants
|
24 participants
n=206 Participants
|
116 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 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 yearsPopulation: Eligible and treated patients are included in this analysis.
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.
Outcome measures
| Measure |
Chemonaive
n=41 Participants
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.
|
Prior Taxane
n=51 Participants
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.
|
Two Prior Chemotherapy Regimens
n=24 Participants
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.
|
|---|---|---|---|
|
Proportion of Patients With PSA Response
|
0.293 Proportion of participants
Interval 0.182 to 0.442
|
0.098 Proportion of participants
Interval 0.052 to 0.271
|
0.042 Proportion of participants
Interval 0.004 to 0.152
|
SECONDARY outcome
Timeframe: 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 entryPopulation: Eligible and treated patients with measurable disease at baseline are included in this analysis.
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.
Outcome measures
| Measure |
Chemonaive
n=26 Participants
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.
|
Prior Taxane
n=38 Participants
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.
|
Two Prior Chemotherapy Regimens
n=13 Participants
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.
|
|---|---|---|---|
|
Proportion of Patients With Measurable Disease Response
|
0.154 Proportion of participants
Interval 0.054 to 0.318
|
0.026 Proportion of participants
Interval 0.001 to 0.119
|
0.077 Proportion of participants
Interval 0.004 to 0.316
|
Adverse Events
Eribulin Mesylate
Serious events: 81 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eribulin Mesylate
n=118 participants at risk
All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.6%
9/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
41.5%
49/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
2.5%
3/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
55.1%
65/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
11.0%
13/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
5/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
3/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.5%
3/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Bladder, hemorrhage
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
5/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, sinus
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Extremity-lower (gait/walking)
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
2.5%
3/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
12.7%
15/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Pain-other
|
0.85%
1/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.7%
2/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Eribulin Mesylate
n=118 participants at risk
All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
62.7%
74/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
62.7%
74/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
6.8%
8/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
47.5%
56/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
9.3%
11/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
69.5%
82/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
14.4%
17/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
39.0%
46/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
32.2%
38/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
28.0%
33/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
16.1%
19/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
13.6%
16/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
33.9%
40/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
9.3%
11/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
9/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
10.2%
12/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.6%
22/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
11.9%
14/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
9.3%
11/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
7/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
6.8%
8/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.7%
15/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
38.1%
45/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Tearing
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
5.1%
6/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.2%
12/118 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60