E3-Hormone Refractory Prostrate Cancer Taxotere Combination - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer Metastatic Hormone Refractory	Drug: Zactima (vandetanib) Drug: Docetaxel Drug: Prednisolone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Docetaxel Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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) ] [ Designated as safety issue: No ]
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Enrollment:	86
Study Start Date:	December 2005
Study Completion Date:	September 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498797

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Gill Pover, MD	AstraZeneca
Study Director:	Peter Langmuir, MD	AstraZeneca

More Information

No publications provided

Responsible Party:	MSD
ClinicalTrials.gov Identifier:	NCT00498797 History of Changes
Other Study ID Numbers:	D4200C00055
Study First Received:	July 9, 2007
Results First Received:	April 27, 2011
Last Updated:	April 27, 2011
Health Authority:	Brazil: National Health Surveillance Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy South Africa: Medicines Control Council Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

prostate cancer
zactima
vandetanib
metastatic

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Docetaxel

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 19, 2013