E3-Hormone Refractory Prostrate Cancer Taxotere Combination

August 25, 2016 updated by: Sanofi

A Phase II, Double-blind, Placebo-controlled, Randomised Study to Assess the Efficacy and Safety of Docetaxel (Taxotere)/Prednisolone/ZD6474 vs Docetaxel/Prednisolone/Placebo in Patients With Hormone Refractory Prostrate Cancer (HRPC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- - Rio de Janeiro, Brazil
    - Research Site
  - Sao Paulo, Brazil
    - Research Site
Germany
- - Hamburg, Germany
    - Research Site
  - Hannover, Germany
    - Research Site
  - Kassel, Germany
    - Research Site
  - Tubingen, Germany
    - Research Site
Hungary
- - Budapest, Hungary
    - Research Site
South Africa
- - Bloemfontein, South Africa
    - Research Site
  - Cape Town, South Africa
    - Research Site
Sweden
- - Umea, Sweden
    - Research Site
  - Uppsala, Sweden
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate Specific Antigen (PSA) 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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With an Objective Disease Progression Event 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)	Number of patients with objective disease progression or death (by any cause in the absence of objective progression)	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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria