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...
Date First Received: July 9, 2007
Last Updated: June 12, 2008
Verified by: AstraZeneca, June 2008
Clinical Trial Phase: Phase 2 | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
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)”
Condition Keyword(s):
Intervention(s):
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
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- assess the efficacy of ZD6474/docetaxel/prednisolone in the treatment of HRPC by the rate of PSA fall
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: AstraZeneca
Research site
Rio de Janeiro Brazil
Research Site
Sao Paulo Brazil
Research Site
Hamburg Germany
Research Site
Hannover Germany
Research Site
Tubingen Germany
Research Site
Kassel Germany
Research Site
Budapest Hungary
Research Site
Bloemfontein South Africa
Research Site
Cape Town South Africa
Research Site
Umea Sweden
Research Site
Uppsala Sweden
Overall Clinical Trial Officials and Contacts
Gill Pover, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00498797
Study ID Number: D4200C00055
ClinicalTrials.gov Identifier: NCT00498797
Health Authority: Brazil: National Health Surveillance Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
