Hormone Refractory, Metastatic, Prostate Cancer
Conditions
Keywords
prostate cancer, zactima, vandetanib, metastatic
Brief summary
The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.
Interventions
DRUGZactima (vandetanib)
DRUGDocetaxel
DRUGPrednisolone
Sponsors
Genzyme, a Sanofi Company
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of PSA * No previous chemotherapy although those patients that have received estramustine can enter the study provided the estramustine was stopped 3 weeks before dosing of study drug * screening PSA values \>20ng/ml. this must be confirmed by two separate measurements at least 2 weeks apart
Exclusion criteria
* Treatment within 4 weeks before randomization and/or whilst on study, treatment with the following: 1)non-approved or experimental drug, 2)treatment with a drug with similar mechanism of action to ZD6474 * concurrent treatment with other anticancer agents, othr than docetaxel and prednisolone as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) Response | PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline | Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With an Objective Disease Progression Event | RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO) | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) |
Countries
Brazil, Germany, Hungary, South Africa, Sweden
Participant flow
Recruitment details
First patient randomised 24 January 2006, last patient randomised 24 Nov 2006, data cut off data 21 July 2007
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib docetaxel/prednisolone/vandetanib | 43 |
| Placebo docetaxel/prednisolone/placebo | 43 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 5 |
| Overall Study | Condition under investigation worsened | 19 | 21 |
| Overall Study | Other | 3 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Vandetanib | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 67 years | 67 years | 67 years |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 43 Participants | 43 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 38 / 43 | 39 / 43 |
| serious Total, serious adverse events | 23 / 43 | 15 / 43 |
Outcome results
Primary
Prostate Specific Antigen (PSA) Response
Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
Time frame: PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib | Prostate Specific Antigen (PSA) Response | 17 Participants |
| Placebo | Prostate Specific Antigen (PSA) Response | 29 Participants |
Secondary
Number of Patients With an Objective Disease Progression Event
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Time frame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib | Number of Patients With an Objective Disease Progression Event | 28 Participants |
| Placebo | Number of Patients With an Objective Disease Progression Event | 26 Participants |