Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC). The secondary objectives were: * To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL); * To assess the overall safety in both treatment arms; * To determine the pharmacokinetics of intravenous (IV) aflibercept in this population; * to determine immunogenicity of IV aflibercept.
Official Title
A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer
Eligibility Criteria
- * Histologically- or cytologically-confirmed prostate adenocarcinoma;* Metastatic disease;* Progressive disease while receiving hormonal therapy or after surgical castration;* Effective castration.
- * Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed \>3 years ago;* Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF receptor inhibitors;* Eastern Cooperative Oncology Group (ECOG) performance status \>2.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
