Status:
COMPLETED
Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aalborg University Hospital
Odense University Hospital
Conditions:
Malignant Gliomas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent
- Histological verification of primary GBM
- Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and temozolamide within last six months)
- Evidence of measurable recurrent progressive primary GBM (CT/MRI scan)
- PS 0-2 (ECOG scale)
- Age \> 18
- Life expectancy \> 3 month
- Normal organ function:
- Platelets \> 125 x 109/l
- Hemoglobin \>6,2 mmol/l
- Leukocytes \> 3 x 109/l
- ACN\> 1,5 x 109/l
- ASAT and/or ALAT \< 3 x upper normal limit
- Bilirubin \< 1,5 x upper normal limit
- Creatinine clearance \> 45 ml/min
- Creatinine \< 1,5 x upper normal limit
- APTT \< normal limit
- INR \< normal limit
- Cholesterol \< 7 mmol/l
- Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.
- Exclusion criteria:
- Radiotherapy or chemotherapy within the last 4 weeks.
- Co-medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids
- Prior EGFR- or VEGFR- based therapy.
- Any condition (medical, social, psychological), which would prevent adequate information and follow-up
- Any other active malignancy or previous malignancies within the last 5 years, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
- No hypercholesterolemia or hypertriglyceridemia (despite lipid-lowering therapy).
- Any significant cardiac disease (New York Heart Association Class II or greater), arrhythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris.
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis, coagulapathy or taking ASA, NSAIDs or clopidogrel
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to day 0
- History of known HIV, Hepatitis B and Hepatitis C negative
- Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound, ulcer or bone fracture
- Pregnancy or breast feeding
- Requires therapeutic anti-coagulation
- Blood pressure \> 150/100 mmHG
- Grade 2 or greater proteinuria
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00463073
Start Date
August 1 2006
End Date
December 1 2008
Last Update
December 11 2008
Active Locations (3)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Odense University Hospital
Odense, Denmark, 5000