Trial Outcomes & Findings for Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer (NCT NCT00577356)
NCT ID: NCT00577356
Last Updated: 2011-01-20
Results Overview
CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen
TERMINATED
PHASE2
6 participants
The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.
2011-01-20
Participant Flow
Recruitment from Feb. 08 through September 08 at Virginia Mason Medical Center
Eligible patients had histologically confirmed adenocarcinoma of the prostate with clinical stage 1-3, no evidence of metastatic disease, and were appropriate candidates for radical prostatectomy with an estimated life expectancy \>10 years.
Participant milestones
| Measure |
CG1940/CG8711 (Immunotherapy Drug)
Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
CG1940/CG8711 (Immunotherapy Drug)
n=6 Participants
Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 - 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
|
|---|---|
|
Age, Customized
<55 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
adenocarcinoma of the prostate and no radiographic evidence of metastatic disease
|
2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Prostate Cancer
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.Population: Study was stopped before analysis occured.
CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen
Outcome measures
Outcome data not reported
Adverse Events
CG1940/CG8711 (Immunotherapy Drug)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place