Trial Outcomes & Findings for Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer (NCT NCT00477087)
NCT ID: NCT00477087
Last Updated: 2017-11-29
Results Overview
Assessed as the time from the 1st dose of study drug to death or disease progression (increase \>25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of \>20% KPS)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
18 months
Results posted on
2017-11-29
Participant Flow
Participant milestones
| Measure |
GM-CSF Plus Mitoxantrone
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
GM-CSF Plus Mitoxantrone
n=10 Participants
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 18 monthsAssessed as the time from the 1st dose of study drug to death or disease progression (increase \>25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of \>20% KPS)
Outcome measures
| Measure |
GM-CSF Plus Mitoxantrone
n=10 Participants
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
Progression-free Survival (PFS)
|
7.5 weeks
Interval 3.0 to 40.0
|
SECONDARY outcome
Timeframe: 18 monthsDefined as the first evidence of a total serum PSA decline of \> 50% from baseline, maintained for at least 28 days, and confirmed with 2 consecutive measurements taken 2 weeks apart.
Outcome measures
| Measure |
GM-CSF Plus Mitoxantrone
n=10 Participants
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)
|
3 Participants
|
SECONDARY outcome
Timeframe: 18 monthsAssessed as the time from the 1st dose of study drug to death.
Outcome measures
| Measure |
GM-CSF Plus Mitoxantrone
n=10 Participants
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
Overall Survival (OS)
|
7.8 Months
Interval 3.0 to 12.6
|
Adverse Events
GM-CSF Plus Mitoxantrone
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GM-CSF Plus Mitoxantrone
n=10 participants at risk
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Pancytopenic
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute renal failure
|
10.0%
1/10 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
GM-CSF Plus Mitoxantrone
n=10 participants at risk
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
|
|---|---|
|
General disorders
Fatigue
|
60.0%
6/10 • Number of events 6 • 3 years
|
|
General disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Eye disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Cardiac disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Infections and infestations
Dyspnea
|
40.0%
4/10 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 3 years
|
|
Nervous system disorders
Night sweats
|
30.0%
3/10 • Number of events 3 • 3 years
|
|
General disorders
Weight gain
|
10.0%
1/10 • Number of events 1 • 3 years
|
Additional Information
Sandy Srinivas, MD; Professor of Medicine (Oncology)
Stanford University Medical Center
Phone: 650-725-2078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place