Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
Condition: Neoplasms; Cancer of the Ovary
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Intervention description: Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.
Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment.; Aflibercept 2.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.
Aflibercept could be reduced by 1 dose level (to 1.0 mg/kg) or 2 dose levels (to 0.5 mg/kg) in case of uncontrolled hypertension or urinary protein >3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment.
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 218.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; angiogenesis; angiogenesis inhibition; VEGF-Trap fusion recombinant protein; Cancer and other neoplasms

Summary:

      This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma
      receiving aflibercept.

      The primary objective was to compare the objective response rate of Aflibercept
      (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered
      intravenously (IV) every 2 weeks with historical control in participants with advanced
      ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant
      to platinum and topotecan and/or liposomal doxorubicin.

      The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential
      biological and pharmacogenomic markers of study drug activity, and health-related quality of
      life.

      This study employed an Independent Review Committee (IRC) for radiological tumor assessments.
      For all tumor assessment-related efficacy variables, two analyses were performed: the primary
      analysis was based on Independent Review Committee (IRC) reviewed data and the secondary
      analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the
      IRC reviewed data is reported for this study.
    

Eligibility criteria:

        Participants who met the following criteria were eligible for the study.

        Inclusion Criteria:

          -  Histologically-confirmed ovarian epithelial (including fallopian tube and primary
             peritoneal) adenocarcinoma.

          -  Prior treatment with at least 2 treatment regimens in the advanced disease treatment
             setting

          -  Platinum-resistant disease defined by relapse or progression of disease during or
             after treatment, or drug intolerance

          -  Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or
             progression of disease during or after treatment, or drug intolerance

          -  Evidence of at least one unidimensional measurable tumor lesion by computed tomography
             (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation
             Criteria in Solid Tumors (RECIST) that has not been treated with surgery or radiation
             therapy

        Exclusion Criteria:

          -  Diagnosis of any second malignancy within the last 5 years, except for adequately
             treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the
             cervix uteri

          -  Prior treatment with a vascular endothelial growth factor (VEGF) or VEGF receptor
             inhibitor

          -  More than 3 chemotherapy regimens in the advanced disease treatment setting

          -  Uncontrolled hypertension

        The above information is not intended to contain all considerations relevant to potential
        participation in a clinical trial.