A Phase 2 interventional study of Temozolomide and Bevacizumab in Glioblastoma Multiforme and Primary Brain Tumor, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-09-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
Elderly patients aged 65 years and older account for approximately 45% of GBM patients, and this figure is expected to rise concurrently with the aging population of most countries. Unfortunately, few trials have been performed in this setting. In elderly patients with good functional status (KPS >70), radiotherapy (RT) prolongs overall survival (OS) without causing a detriment in quality of life compared with palliative care alone. Recently, it was shown that TMZ could be an alternative to RT. In elderly patients with poor functional status at symptom onset (KPS \< 70), RT does not appear to be a satisfactory option in this frail population; however, investigators previously found that TMZ alone was associated with improvements in functional status in 1/3 of cases and appeared to increase survival compared with supportive care alone, especially in methylated MGMT promoter patients.
Bevacizumab (Bev) is an antiangiogenic monoclonal antibody targeting VEGF (vascular endothelial growth factor) that is currently used in recurrent GBM, particularly in combination with alkylating agents. Its effect as first line treatment in combination with TMZ and RT is controversial.
In this study, investigators evaluated the efficacy and safety of the upfront combination of TMZ + Bev as an initial treatment for elderly patients with GBM and impaired functional status (KPS \<70).
1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's enrollment of 70 is above the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single experimental arm with two drugs : Temozolomide and Bevacizumab
Drug: Temozolomide · Drug: Bevacizumab
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 (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.
Median Overall Survival (OS)
OS calculated from the date of surgery until death from any cause or up to 36 months.
Time frame: OS calculated from the date of surgery until death or up to 36 months.
Progression-free survival (PFS)
PFS calculated from the date of surgery to the date of progression or death or up to 36 months.
Time frame: PFS calculated from the date of surgery until the date of first documented progression or up to 36 months.
Toxicity grade according to the National Cancer Institute Common Toxicity Criteria (NCI CTCAE, version 3.0)
Assessment every 2 weeks until 12 months by physical and neurological examinations, complete blood counts and urine strip tests. Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTCAE, version 3.0).
Time frame: Assessment every 2 weeks until 12 months
Health-related quality of life using QLQ-C30 questionnaire
The QLQ-C30 questionnaire includes 30 questions comprising five functioning scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, vomiting and pain) and six single item scales (dyspnea, insomnia, constipation, anorexia, diarrhea, and financial difficulties).
Time frame: at baseline and every month until 12 months
Health-related quality of life using QLQ-BN20
The QLQ-BN20 questionnaire includes 20 items covering functional deficits, symptoms, toxic effects of treatment, and uncertainty about the future.
Time frame: at baseline and every month until 12 months
Cognitive assessment MMSEs
The MMSE was used as a measure of general cognitive status. Higher scores on this exam, which uses a 30-point scale, indicate better cognitive function.
Time frame: at baseline and they were repeated every month until 12 months
Radiological responses
Response assessment in neuro-oncology (RANO) criteria
Time frame: Neuroimaging evaluation repeated every 2 months until 12 months
Plan to share: No
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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