E3-Hormone Refractory Prostrate Cancer Taxotere Combination

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498797
• Other study ID #: D4200C00055
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: April 27, 2011
• Start date: December 2005
• Est. completion date: September 2008

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacySouth Africa: Medicines Control CouncilSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Refractory
• Metastatic
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zactima (vandetanib)

• Docetaxel

• Prednisolone

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Brazil,  Germany,  Hungary,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	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)	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)	No