E3-Hormone Refractory Prostrate Cancer Taxotere Combination

Phase 2

Completed

• Conditions: Prostate Cancer; Metastatic; Hormone Refractory

• Registration Number: NCT00498797
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-07
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Study Completion: 2008-09
• Results First Submitted: 2011-04-27
• Results First Submitted QC: 2011-04-27
• Results First Posted: 2011-05-24
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Research Site; 🇸🇪 Uppsala, Sweden

Research site; 🇧🇷 Rio de Janeiro, Brazil