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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Prostatic Neoplasms; Neoplasm Metastasis

Treatments: Drug: Placebo (for aflibercept); Drug: Aflibercept; Drug: Prednisone or Prednisolone; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519285

EFC6546

2006-004756-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first.

The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.

Enrollment: 1,224 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,224 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Treatment:

Drug: Docetaxel

Drug: Prednisone or Prednisolone

Drug: Placebo (for aflibercept)

Aflibercept

Experimental group

Description:

Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Treatment:

Drug: Docetaxel

Drug: Prednisone or Prednisolone

Drug: Aflibercept