Trial Outcomes & Findings for Docetaxel (Taxotere) and Imatinib Mesylate (Gleevec) in Hormone Refractory Prostate Cancer (NCT NCT00861471)
NCT ID: NCT00861471
Last Updated: 2016-06-30
Results Overview
PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
up to 9 months
Results posted on
2016-06-30
Participant Flow
12 patients were enrolled between Sep. 2006 and Nov. 2008 for the Phase II part of the study in New York University Medical center and affiliated hospitals.
Once the optimal combination dose of Docetaxel (Taxotere) and Gleevec (Imatinib Mesylate) was determined in the Phase I part, the study proceeded to Phase II. There were 12 patients in Phase I and Phase II, respectively. The results reported here are only for Phase II.
Participant milestones
| Measure |
Docetaxel +Gleevec
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Docetaxel +Gleevec
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
treatment for lumbar laminectomy
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Docetaxel (Taxotere) and Imatinib Mesylate (Gleevec) in Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel +Gleevec
n=12 Participants
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 9 monthsPopulation: The analysis was based on intent-to-treat population.
PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.
Outcome measures
| Measure |
Docetaxel +Gleevec
n=12 Participants
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Percentage of Participants With Prostate Specific Antigen (PSA) Response
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: The analysis was based on intent-to-treat population
PSA was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.
Outcome measures
| Measure |
Docetaxel +Gleevec
n=12 Participants
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression
|
16 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Based on the participants with measurable disease
Measurable disease response is defined as the number of participants whose best response is complete response or partial response over the number of patients with measurable desease according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
Docetaxel +Gleevec
n=5 Participants
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Percentage of Participants With Measurable Disease Response
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Based on intent-to-treat population
Time to PSA pregression is defined as the time at which therapy statred and ends when the PSA increased by 50% above the nadir confirmed on a second determination.
Outcome measures
| Measure |
Docetaxel +Gleevec
n=12 Participants
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Time to PSA Progression
|
188 days
Interval 85.0 to 279.0
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Based on intent-to-treat population
Overall survival time is the time from the start of therapy till death. Median overall survival reported here is the time when 50% of the participants are alive.
Outcome measures
| Measure |
Docetaxel +Gleevec
n=12 Participants
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Median Overall Survival Time
|
24.9 months
Interval 14.3 to 35.4
|
Adverse Events
Docetaxel +Gleevec
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel +Gleevec
n=12 participants at risk
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 1 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.3%
1/12 • Number of events 1 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
16.7%
2/12 • Number of events 2 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Infections and infestations
infection with normal ANC
|
8.3%
1/12 • Number of events 1 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
pain-other
|
8.3%
1/12 • Number of events 1 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
Other adverse events
| Measure |
Docetaxel +Gleevec
n=12 participants at risk
21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m\^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
|
|---|---|
|
General disorders
abdominal pain or cramping
|
16.7%
2/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Immune system disorders
allergic rhinitis
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
41.7%
5/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
anorexia
|
33.3%
4/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
constipation
|
33.3%
4/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
constitutioanl symptoms-other
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
2/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
dehydration
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
dermotology/ skin- other
|
33.3%
4/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
diarrhea (with colostomy)
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
diarrhea (without colostomy)
|
41.7%
5/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
16.7%
2/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
41.7%
5/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Cardiac disorders
edema
|
41.7%
5/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
fatigue
|
75.0%
9/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
fever
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
gastrointestinal- other
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Blood and lymphatic system disorders
hemoglobin
|
66.7%
8/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Metabolism and nutrition disorders
hyponatremia
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Nervous system disorders
insomnia
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Blood and lymphatic system disorders
leukocytes
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Blood and lymphatic system disorders
lymphatics
|
25.0%
3/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
16.7%
2/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
nail changes
|
33.3%
4/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
nausea
|
58.3%
7/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Nervous system disorders
neuropathy /sensory
|
58.3%
7/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Blood and lymphatic system disorders
neutrophils/ granulocytes
|
16.7%
2/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Eye disorders
ocular/ visual -other
|
25.0%
3/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
pain -other
|
25.0%
3/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Cardiac disorders
palpitations
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Blood and lymphatic system disorders
platelets
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Skin and subcutaneous tissue disorders
rash/ desquamation
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
rigors/ chills
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Cardiac disorders
sinus tachycardia
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
stomatitis/ pharyngitis
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
taste disturbance
|
33.3%
4/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Eye disorders
tearing
|
25.0%
3/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
Gastrointestinal disorders
vomiting
|
25.0%
3/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
weight gain
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
|
General disorders
weight loss
|
8.3%
1/12 • on study (up to 9 months) plus 30 days after
adverse events were collected by patient reporting, investigator questioning, physical exams, lab tests, etc.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place