Bevacizumab and Lomustine for Recurrent GBM

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT01290939
Phase
PHASE3
Status
Completed

Conditions

  • Cognition Disorders
  • Disability Evaluation
  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • lomustine — DRUG
  • DNA methylation analysis — GENETIC
  • laboratory biomarker analysis — OTHER
  • cognitive assessment — PROCEDURE
  • quality-of-life assessment — PROCEDURE

Study Details

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab given together with lomustine is most effective in treating patients with glioblastoma multiforme in first recurrence. PURPOSE: The primary objective of this study is to investigate whether the addition of bevacizumab to lomustine improves overall survival (OS) in patients with recurrent glioblastoma compared to treatment with lomustine alone.

Key Dates

First listed
Feb 7, 2011
Start date
Oct 31, 2011
Status verified
Feb 2021
Primary completion
Oct 31, 2015
Completion
Apr 30, 2020

Study Design

Enrollment
592 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Lomustine 90 mg/m² every 6 weeks (cap. 160 mg) + bevacizumab 10 mg/kg every 2 weeks (at further progression treatment will be according to investigators discretion). In the absence of hematological toxicity \> grade 1 during the first cycle the dose of lomustine can be escalated to 110 mg/m² (cap 200 mg) in their second cycle.
  • Active Comparator: Arm 2
    Lomustine single agent 110 mg/m² every 6 weeks (cap. 200 mg) (at further progression treatment will be according to investigators discretion).

Primary Outcome Measure

Overall Survival [ Time Frame: Time to event ]

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