A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult patients, >/=18 years of age
- Diagnosis of recurrent glioblastoma multiforme (Grade IV)
- Previous treatment with temozolomide and radiotherapy
- First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
- Adequate hematological, biochemical and organ functions
Exclusion criteria
- Previous treatment with Avastin or other anti-angiogenic drugs
- Residual relevant toxicity resulting from previous therapy
- Radiotherapy within the 3 months prior to the diagnosis of disease progression
- Chemotherapy in the previous 4 weeks
- Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
- Clinically significant cardiovascular diseases
Trial design
Primary purpose
Allocation
Interventional model
Masking
91 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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