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A Phase II Trial With Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas and Progression After Radiation Therapy and Temozolamide

Phase 2
18 Years
Not Enrolling
Malignant Gliomas

Thank you

Trial Information

A Phase II Trial With Cetuximab, Bevacizumab and Irinotecan for Patients With Malignant Glioblastomas and Progression After Radiation Therapy and Temozolamide

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Principal Investigator

Ulrik Lassen, MD., PH.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Dept. of Oncology


Denmark: Danish Medicines Agency

Study ID:




Start Date:

August 2006

Completion Date:

December 2008

Related Keywords:

  • Malignant Gliomas
  • Progressive primary Glioblastoma multiforme
  • Glioblastoma
  • Glioma