E3-Hormone Refractory Prostrate Cancer Taxotere Combination

Sanofi86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostate Cancer Metastatic Hormone Refractory

Interventions

Zactima (vandetanib)DRUG

DocetaxelDRUG

PrednisoloneDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Research site

Rio de Janeiro, Brazil

Research Site

São Paulo, Brazil

Research Site

Hamburg, Germany

Research Site

Hanover, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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