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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00498797

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Docetaxel Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

assess the efficacy of ZD6474/docetaxel/prednisolone in the treatment of HRPC by the rate of PSA fall

Estimated Enrollment:	80
Study Start Date:	December 2005
Study Completion Date:	November 2006

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
Tubingen, Germany
Research Site
Kassel, 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

Study ID Numbers:	D4200C00055
Study First Received:	July 9, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00498797
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

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Methylprednisolone
Prednisolone
Methylprednisolone acetate

Prednisolone acetate
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents
Neuroprotective Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009