Status:
COMPLETED
Bevacizumab and Irinotecan or Bevacizumab and Temozolomide With Concomitant Radiotherapy for Primary Glioblastoma Multiforme (GBM)
Lead Sponsor:
Ulrik Lassen
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Significant activity (radiographic response rates of approximately 60%) has recently been demonstrated in phase II studies in patients with relapsed GBM from the combined use of Irinotecan (CPT-11) an...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed informed consent
- Histological verified primary glioblastoma multiforme
- No prior therapy for GBM, except for primary surgical resection or biopsy
- PS 0-2
- Age \> 18
- Expected survival \> 3 months
- Adequate liver, renal and bone-marrow function, determined as:
- Thrombocytes \> 100 x 109/liter
- Hemoglobin \>6.2 mmol/liter
- Leukocytes \> 3 x 109/liter
- Neutrophil granulocytes \> 1.5 x 109/liter
- ASAT and/or ALAT \< 3 x upper normal limit
- Bilirubin \< 1.5 x upper normal limit
- Serum-creatinin \< upper normal limit or glomerular filtration rate \>60 ml/min (corrected for age) determined by measurement of clearance of Cr-EDTA
- APTT \< upper normal limit
- INR \< upper normal limit
- Fertile women of childbearing age must use proper anti-conception (oral contraceptives, IUD and/or condom). Fertile men must use condom
- No sign of cerebral bleeding on cerebral MR-scanning at baseline.
- Exclusion criteria:
- Previous therapy of GBM, including radiotherapy and the use of biological " targeted" drug, e.g. drugs targeted against the VEGF- or EGFR pathway
- Concurrent use of medication that can affect the interpretation of the results from the study, e.g. use of immunosuppressive drugs, except corticosteroids
- Conditions (medical, social or physical) that may compromise proper information and/or follow-up
- Other concurrent or previous cancer within 5 years, except adequately treated basal or planocellular skin cancer, or cervical carcinoma in situ
- Significant heart disease (according to the New York Heart Association class II or more severe), clinically significant arrhythmia or unstable angina pectoris/acute myocardial infarction within last 6 months
- Clinical significant peripheral arterial disease
- Known or suspected disorders of coagulation or concurrent therapy with ASA, NSAID or clopidogrel
- Major surgery, open biopsy or greater trauma, or expectations thereof, within 28 days prior to start of therapy
- Minor surgery or needle biopsy, or expectations thereof, within 7 days prior to start of therapy
- Known or suspected abdominal fistulas, gastrointestinal perforations or intra-abdominal abscesses within 6 months prior to start of therapy
- Chronic inflammatory intestinal disease and/or intestinal obstruction
- Known or active HIV or Hepatitis B/C infection
- Concurrent ongoing significant infection or diabetes mellitus not adequately controlled medically
- Clinically significant non-healing ulcers
- Active ventricular or duodenal ulcers within 6 months prior to start of therapy
- Recent bone-fracture (\<3 months)
- Pregnancy or lactation
- Need for systemic anticoagulant therapy at time of start of therapy
- Blood pressure \> 150/100 mmHg (patients are allowed to receive proper antihypertensive medication)
- Proteinuria ≥ 1 gram/day
- Known allergy toward irinotecan (or related substance) or vehicle
- Known allergy toward temozolomide (or related substance) or vehicle
- Known allergy toward bevacizumab (or related substance) or vehicle
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00817284
Start Date
November 1 2008
End Date
November 1 2011
Last Update
November 30 2011
Active Locations (3)
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1
Århus Hospital
Aarhus, Denmark
2
Rigshospitalet
Copenhagen, Denmark
3
Odense Hospital
Odense, Denmark