Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Not Recruiting

Trial ID: NCT00519285


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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - Histologically- or cytologically-confirmed prostate adenocarcinoma;

   - Metastatic disease;

   - Progressive disease while receiving hormonal therapy or after surgical castration;

   - Effective castration.

Exclusion Criteria:

   - 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.


drug: Aflibercept

drug: Placebo (for aflibercept)

drug: Docetaxel

drug: Prednisone or Prednisolone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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