NCT00757692

Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

A Phase II Randomised Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer Hypothesis There will be a PSA response when Vandetanib is given in combination with Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.

Detailed description

With the advent of PSA surveillance, many patients diagnosed with hormone refractory disease, have PSA rising disease only, are asymptomatic, with no evidence of metastatic disease. There is no standard of care in this patient population. A standard treatment in this population has been the addition of a non-steroidal anti androgen such as bicalutamide. PSA response rate (defined as a 50% decrease) have been reported in 20% range with bicalutamide. Even in patients with hormone refractory prostate cancer (HRPC) and metastases that have no cancer related symptoms, initiation of chemotherapy is controversial given the palliative nature of chemotherapy and potential for serious toxicity. These patients are generally well enough to to undergo trials of novel agents and achieve adequate drug exposure, such that any cytostatic effect will be apparent.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Vandetanib	Vandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously
DRUG	Bicalutamide	Bicalutamide at 50 mg will be administered orally, daily and continuously.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-02-01
• Completion: 2012-11-01
• First posted: 2008-09-23
• Last updated: 2013-02-20

Locations

4 sites across 1 country: Canada