Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status
NCT ID: NCT02898012
Last Updated: 2016-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2010-10-31
2013-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Temozolomide and Bevacizumab
Single experimental arm with two drugs : Temozolomide and Bevacizumab
Temozolomide
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
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.
Interventions
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Temozolomide
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
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.
Eligibility Criteria
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Inclusion Criteria
* Patients aged ≥ 70 years
* KPS \>30 and \< 70
* Life expectancy \> or = 8 weeks
* Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy.
* CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage.
* Included to health social security system
* Medical assessment previous to inclusion
* Informed consent form
Exclusion Criteria
* Hemoglobin level \< 9 g%
* Absolute neutrophil count \< 1500
* Platelet count \< 100.000
* ASAT or ALAT levels more than 3 times the upper limit of normal.
* Bilirubin levels more than 2 times the upper limit of normal
* Creatinin more than 1.5 times the upper limit of normal
* Untreated high blood pressure \>150/100 mmHg
* Congestive cardiac failure
* Proteinuria \> 1 gr/24h
* INR \> 1.5 the upper limit of normal
* Recent symptomatic haemorrhage
* History of abnormal wound healing
* Gastrointestinal fistula
* Haemoptysis \> grade 2 (NCI-CTC)
* Intracranial abscess
* Coagulation disorder
* Active infection requiring intravenous antibiotics
* Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months
* Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer)
* Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters.
70 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Yves Delattre, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Pôle MSN, Groupe Hospitalier Pitié-Salpêtrière
Locations
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Groupe Hospitalier Pitié-Salpêtrière
Paris, Paris, France
Countries
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References
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Other Identifiers
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P081213
Identifier Type: -
Identifier Source: org_study_id
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