Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer (VENICE)


Tracking Information

Start Date  ICMJEAugust 2007
Estimated Primary Completion DateJune 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)		Overall survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: August 21, 2007)		Overall survival
Change HistoryComplete list of historical versions of study NCT00519285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)		PSA measurement, pain measurement, occurrence of skeletal related events [ Time Frame: Study period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: August 21, 2007)		PSA measurement, pain measurement, occurrence of skeletal related events

Descriptive Information

Brief Title  ICMJEAflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Official Title  ICMJEA 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
Brief Summary

The primary objective of the study is to demonstrate an improvement of overall survival in patients treated with aflibercept versus placebo, in patients receiving docetaxel/ prednisone.

Main secondary endpoints gather prostate-specific antigen (PSA) response, pain response,time to occurrence of skeletal related events and progression free survival (PFS), as well as safety, pharmacokinetics and immunogenicity.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Prostatic Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: Aflibercept (AVE0005)
    Associated to docetaxel and prednisone or prednisolone
  • Drug: Placebo
    Associated to docetaxel and prednisone or prednisolone
Study Arms / Comparison Groups
  • Arm A: Experimental
    Intervention: Drug: Aflibercept (AVE0005)
  • Arm B: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1200
Estimated Completion DateJune 2012
Estimated Primary Completion DateJune 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 VEGF inhibitors or VEGF receptor inhibitors
  • Eastern Cooperative Oncology Group performance status > 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

GenderMale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Registry ICDGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Croatia,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00519285
Responsible PartyICD Study Director, sanofi-aventis
Study ID Numbers  ICMJEEFC6546, EUDRACT : 2006-004756-20
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJERegeneron Pharmaceuticals
Investigators  ICMJE
Study Director:ICDSanofi-Aventis
Information Provided BySanofi-Aventis