Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostatic Neoplasms Neoplasm Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Group Type PLACEBO_COMPARATOR

Placebo (for aflibercept)

Intervention Type DRUG

Sterile aqueous buffered solution identical to aflibercept

1-hour IV on Day 1 of each 3-Week cycle

Docetaxel

Intervention Type DRUG

Marketed formulation

75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)

Prednisone or Prednisolone

Intervention Type DRUG

Marketed formulation

5 mg twice daily PO from day 1 continuously

Aflibercept

Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone

Group Type EXPERIMENTAL

Aflibercept

Intervention Type DRUG

25 mg/ml solution

6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle

Docetaxel

Intervention Type DRUG

Marketed formulation

75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)

Prednisone or Prednisolone

Intervention Type DRUG

Marketed formulation

5 mg twice daily PO from day 1 continuously

Interventions

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Aflibercept

25 mg/ml solution

6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle

Intervention Type DRUG

Placebo (for aflibercept)

Sterile aqueous buffered solution identical to aflibercept

1-hour IV on Day 1 of each 3-Week cycle

Intervention Type DRUG

Docetaxel

Marketed formulation

75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo)

Intervention Type DRUG

Prednisone or Prednisolone

Marketed formulation

5 mg twice daily PO from day 1 continuously

Intervention Type DRUG

Other Intervention Names

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AVE0005 ZALTRAP®) Taxotere®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Macquarie Park, , Australia

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Sanofi-Aventis Administrative Office

Diegem, , Belgium

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Sanofi-Aventis Administrative Office

São Paulo, , Brazil

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Sanofi-Aventis Administrative Office

Laval, , Canada

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Sanofi-Aventis Administrative Office

Providencia Santiago, , Chile

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Sanofi-Aventis Administrative Office

City of Zagreb, , Croatia

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Sanofi-Aventis Administrative Office

Prague, , Czechia

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Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

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Sanofi-Aventis Administrative Office

Tallinn, , Estonia

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Sanofi-Aventis Administrative Office

Paris, , France

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Sanofi-Aventis Administrative Office

Frankfurt, , Germany

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Sanofi-Aventis Administrative Office

Hong Kong, , Hong Kong

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Sanofi-Aventis Administrative Office

Budapest, , Hungary

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Sanofi-Aventis Administrative Office

Netanya, , Israel

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Sanofi-Aventis Administrative Office

Milan, , Italy

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Sanofi-Aventis Administrative Office

Gouda, , Netherlands

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Sanofi-Aventis Administrative Office

Warsaw, , Poland

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Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

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Sanofi-Aventis Administrative Office

Moscow, , Russia

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Sanofi-Aventis Administrative Office

Singapore, , Singapore

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Sanofi-Aventis Administrative Office

Gauteng, , South Africa

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Sanofi-Aventis Administrative Office

Seoul, , South Korea

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Sanofi-Aventis Administrative Office

Barcelona, , Spain

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Sanofi-Aventis Administrative Office

Bromma, , Sweden

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Sanofi-Aventis Administrative Office

Geneva, , Switzerland

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Sanofi-Aventis Administrative Office

Taipei, , Taiwan

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Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Site Status

Sanofi-Aventis Administrative Office

Kiev, , Ukraine

Site Status

Sanofi-Aventis Administrative Office

Guildford Surrey, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Chile Croatia Czechia Denmark Estonia France Germany Hong Kong Hungary Israel Italy Netherlands Poland Portugal Russia Singapore South Africa South Korea Spain Sweden Switzerland Taiwan Turkey (Türkiye) Ukraine United Kingdom