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Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Not Recruiting
Trial ID: NCT00519285
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
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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.
Intervention(s):
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
650-498-7061