Trial Outcomes & Findings for GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere (NCT NCT00274287)
NCT ID: NCT00274287
Last Updated: 2019-03-28
Results Overview
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
up to 21 months
Results posted on
2019-03-28
Participant Flow
Participant milestones
| Measure |
GM-CSF (Leukine)
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
GM-CSF (Leukine)
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
subject non-compliance
|
1
|
Baseline Characteristics
GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
Baseline characteristics by cohort
| Measure |
GM-CSF (Leukine)
n=15 Participants
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
|
|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Gleason Score >=7
|
14 Participants
n=5 Participants
|
|
Median time from diagnosis to GM-CSF
|
71 months
n=5 Participants
|
|
Median number of prior therapies
|
2 therapies
n=5 Participants
|
|
median PSA
|
51.7 ng/dl
n=5 Participants
|
|
Median alkphos
|
97 U/L
n=5 Participants
|
|
Prior initial therapy
RT (radiation therapy)
|
5 Participants
n=5 Participants
|
|
Prior initial therapy
ADT (androgen deprivation therapy)
|
7 Participants
n=5 Participants
|
|
Prior initial therapy
RP (radical prostatectomy)
|
3 Participants
n=5 Participants
|
|
Site of Metastases
bone
|
7 Participants
n=5 Participants
|
|
Site of Metastases
visceral disease
|
1 Participants
n=5 Participants
|
|
Site of Metastases
viseral and bone
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 21 monthsPopulation: all evaluable participants
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
Outcome measures
| Measure |
GM-CSF (Leukine)
n=13 Participants
Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
|
|---|---|
|
Time to Disease Progression (TTP)
TTP from GM-CSF
|
6 months
Interval 2.0 to 12.0
|
|
Time to Disease Progression (TTP)
TTP from chemotherapy
|
11 months
Interval 9.0 to 21.0
|
SECONDARY outcome
Timeframe: up to 21 monthsPopulation: all evaluable participants
Biochemical PR (Partial Response) was defined as a PSA that decreases by 50% and maintains by at least 3 weeks by confirmatory measurement. Biochemical SD (stable disease) was defined as a PSA that was increased by less than 25% or decreased by less than 50% Biochemical PD (progressive disease) was defined as an increase of at least 25% confirmed 3 weeks after.
Outcome measures
| Measure |
GM-CSF (Leukine)
n=13 Participants
Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
|
|---|---|
|
Response Rate (PSA)
PSA PD
|
7 Participants
|
|
Response Rate (PSA)
PSA PR
|
2 Participants
|
|
Response Rate (PSA)
PSA SD
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 21 monthsPopulation: all evaluable participants
PR was defined as more than 30% decrease in the sum of the longest diameter of measurable lesions compared to baseline. SD was defined when lesions did not meet criteria for PR or PD. PD was defined as more than 20% increase in the sum of the longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions at imaging studies. The appearance of 2 or more new boney lesions on bone scan development of cord compression, and pathologic fractures constituted PD.
Outcome measures
| Measure |
GM-CSF (Leukine)
n=13 Participants
Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
|
|---|---|
|
Response Rate (Radiographic)
Radiographic PD
|
4 Participants
|
|
Response Rate (Radiographic)
Radiographic SD
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 44 monthsPopulation: all evaluable participants
Outcome measures
| Measure |
GM-CSF (Leukine)
n=13 Participants
Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
|
|---|---|
|
Median Overall Survival (OS)
OS from GM-CSF
|
12 months
Interval 2.0 to 38.0
|
|
Median Overall Survival (OS)
OS from chemotherapy
|
21 months
Interval 10.0 to 44.0
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: all evaluable participants
Outcome measures
| Measure |
GM-CSF (Leukine)
n=13 Participants
Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
|
|---|---|
|
Median Number of GM-CSF Cycles
|
6 months
Interval 2.0 to 12.0
|
Adverse Events
GM-CSF (Leukine)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GM-CSF (Leukine)
n=15 participants at risk
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
|
|---|---|
|
Cardiac disorders
Angina
|
6.7%
1/15 • Number of events 2 • 24 months
|
|
Vascular disorders
edema
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
dehydration
|
6.7%
1/15 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
pnuemonia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
weakness
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
General disorders
meningioma
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
diarrhea
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
dizziness
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
bowel obstruction
|
6.7%
1/15 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Cardiac disorders
A Fib
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
Port infection
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
syncope
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Infections and infestations
Thrush
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Vascular disorders
DVT
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
fatigue
|
6.7%
1/15 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
GM-CSF (Leukine)
n=15 participants at risk
Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
|
|---|---|
|
Blood and lymphatic system disorders
albumin low
|
40.0%
6/15 • Number of events 6 • 24 months
|
|
Blood and lymphatic system disorders
alk phos
|
26.7%
4/15 • Number of events 4 • 24 months
|
|
General disorders
alopecia
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Metabolism and nutrition disorders
anorexia
|
26.7%
4/15 • Number of events 4 • 24 months
|
|
Surgical and medical procedures
arthralgia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
AST high
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
balance difficulty
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
bleeding
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
breathing difficult
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Bruising
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Hepatobiliary disorders
BUN
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
Calcium low
|
40.0%
6/15 • Number of events 6 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Carbon Dioxide
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
cellulitis
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
chills
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
chloride low
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Blood and lymphatic system disorders
chloride high
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
concentration difficulty
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
confusion
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Eye disorders
conjunctiva abnormal
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
constipation
|
33.3%
5/15 • Number of events 5 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
creatinine low
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Psychiatric disorders
depression
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Nervous system disorders
disoriented
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
DOE
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
dysphasia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Infections and infestations
E coli
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Ear and labyrinth disorders
ear pain
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Eye disorders
eyes dry
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Eye disorders
eyes watery
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
fall
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Infections and infestations
fever
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Nervous system disorders
headache
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Cardiac disorders
heart beat rapid
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
General disorders
hives
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Ear and labyrinth disorders
HOH
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Endocrine disorders
hot flashes
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Endocrine disorders
hyperglycemia
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
hyperlipedmia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Cardiac disorders
hypertension
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
hyponatremia
|
40.0%
6/15 • Number of events 6 • 24 months
|
|
Renal and urinary disorders
incontinence
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
insomnia
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
itching
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
leg ulcer
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
libido decreased
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
lightheadedness
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
lymphopenia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Nervous system disorders
memory loss
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
General disorders
mouth dryness
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
mouth sores
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
nail changes
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
nausea
|
46.7%
7/15 • Number of events 7 • 24 months
|
|
Nervous system disorders
neuralgia
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
nocturia
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
General disorders
pain
|
33.3%
5/15 • Number of events 5 • 24 months
|
|
Blood and lymphatic system disorders
phosporus low
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
potassium low
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
protein low
|
33.3%
5/15 • Number of events 5 • 24 months
|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
5/15 • Number of events 5 • 24 months
|
|
Skin and subcutaneous tissue disorders
redness
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Eye disorders
seeing difficulties
|
40.0%
6/15 • Number of events 6 • 24 months
|
|
Nervous system disorders
seizure
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
sinus problems
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
skin dry
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Infections and infestations
sore throat
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
swallowing difficulty
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
swelling
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
General disorders
sweats
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
20.0%
3/15 • Number of events 3 • 24 months
|
|
Renal and urinary disorders
urination problems
|
13.3%
2/15 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
urinary retention
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
vomiting
|
26.7%
4/15 • Number of events 4 • 24 months
|
|
Gastrointestinal disorders
weight loss
|
40.0%
6/15 • Number of events 6 • 24 months
|
|
Skin and subcutaneous tissue disorders
welts
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
6.7%
1/15 • Number of events 1 • 24 months
|
|
Cardiac disorders
CAD
|
6.7%
1/15 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60