Phase 2 N=86 Randomized Double-blind Treatment

E3-Hormone Refractory Prostrate Cancer Taxotere Combination

Prostate Cancer · Metastatic · Hormone Refractory

Bottom Line

View on ClinicalTrials.gov: NCT00498797 ↗

Enrolled (actual)

Serious AEs

44.2%

Results posted

May 2011

Primary outcome: Primary: Prostate Specific Antigen (PSA) Response — 17; 29 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Zactima (vandetanib) (Drug); Docetaxel (Drug); Prednisolone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Sanofi
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Prostate Specific Antigen (PSA) Response	17; 29	—
SECONDARY Number of Patients With an Objective Disease Progression Event	28; 26	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00498797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.