Overview
E3-Hormone Refractory Prostrate Cancer Taxotere Combination
Status:
Completed
Completed
Trial end date:
2008-09-01
2008-09-01
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SanofiCollaborator:
Genzyme, a Sanofi CompanyTreatments:
Docetaxel
Hormones
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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