Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT02898012
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme
  • Primary Brain Tumor

Eligibility Criteria

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

Interventions

  • Temozolomide — DRUG
    Temozolomide (TMZ) Temozolomide (TMZ) administered at 130-150 mg/m2 for 5 consecutive days every 4 weeks up to 12 cycles. IV or oral administration was allowed according to the clinical status. TMZ starts at 130 mgs/m2 and increase to 150 mgs/m2 during the second cycle in the absence of hematologic toxicity. In the case of grade 3 or 4 toxicity, the dose for the next cycle is decreased to 110 mg/m2. If the grade 3 or 4 toxicity persists at a dose of 110 mg/m2, treatment is discontinued.
  • Bevacizumab — DRUG
    Bevacizumab (Bev) administered at a dose of 10 mgs/kg every 2 weeks. Bev was interrupted in cases of wound healing disturbances, gastrointestinal perforation, intestinal occlusion, fistula, uncontrolled hypertension, nephrotic syndrome, grade 4 or recurrent grade 3 thromboembolic events, arterial thrombosis, hemorrhage \> grade 2, left ventricular failure, or posterior reversible leukoencephalopathy.

Study Details

The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) \<70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS \<70.

Key Dates

First listed
Sep 13, 2016
Start date
Oct 31, 2010
Status verified
Jul 2016
Primary completion
May 31, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Temozolomide and Bevacizumab
    Single experimental arm with two drugs : Temozolomide and Bevacizumab

Primary Outcome Measure

Median Overall Survival (OS) [ Time Frame: OS calculated from the date of surgery until death or up to 36 months. ]

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