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Sponsors and Collaborators: |
British Columbia Cancer Agency AstraZeneca |
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Information provided by: | British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT00757692 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Vandetanib Drug: Bicalutamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 74 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Vandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously
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Drug: Vandetanib
Vandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously
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B: Active Comparator
Bicalutamide at 50 mg will be administered orally, daily and continuously.
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Drug: Bicalutamide
Bicalutamide at 50 mg will be administered orally, daily and continuously.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hormone Therapy
Exclusion Criteria:
Patients who require the following medication:concomittant use of warfarin, Class 1A antiarrythmics (e.g., quinidine, procainamide, disopyramide) Class
1C antiarrhythmics (e.g.,flecainide, propafenone), Class III antiarrhythmics (e.g., amiodarone, sotalol, ibutilide), antipsychotics (e.g., thioridazine, chlorpromazine, pimozide, haloperidol, droperidol), tri/tetracyclic antidepressants (e.g., amitriptyline, imipramine, maprotiline), ketoconazole, antiepileptics and macrolide antibiotics.
Contact: Kim Chi, MD | 604-877-6000 ext 2746 | kchi@bccancer.bc.ca |
Canada, British Columbia | |
BC Cancer Agency - Vancouver Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
BC Cancer Agency - Centre for Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 |
Study Chair: | Kim Chi, MD | BC Cancer Agency - Vancouver Centre |
Responsible Party: | BC Cancer Agency ( Dr Kim Chi ) |
Study ID Numbers: | OZM-011 |
Study First Received: | September 19, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00757692 History of Changes |
Health Authority: | Canada: Health Canada |
Vandetanib (ZD6474) Hormone Refractory |
Prostate Cancer Chemotherapy Naïve |
Androgen Antagonists Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bicalutamide |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Androgens |
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male |
Hormones Pharmacologic Actions Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Bicalutamide Prostatic Neoplasms |